Trial Outcomes & Findings for Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes (NCT NCT02252965)
NCT ID: NCT02252965
Last Updated: 2017-01-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
532 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2017-01-24
Participant Flow
Participant milestones
| Measure |
Metformin IR
Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Overall Study
STARTED
|
267
|
265
|
|
Overall Study
Safety Population
|
261
|
264
|
|
Overall Study
COMPLETED
|
227
|
222
|
|
Overall Study
NOT COMPLETED
|
40
|
43
|
Reasons for withdrawal
| Measure |
Metformin IR
Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
14
|
|
Overall Study
Lost to Follow-up
|
16
|
8
|
|
Overall Study
Protocol Violation
|
4
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
|
Overall Study
Other
|
4
|
5
|
Baseline Characteristics
Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Metformin IR
n=267 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=265 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Gender
Female
|
112 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Gender
Male
|
155 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Outcome measures
| Measure |
Metformin IR
n=208 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=204 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
|
-1.61 Percentage of HbA1c
Standard Error 0.05
|
-1.58 Percentage of HbA1c
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: The safety population included all subjects who received at least 1 dose of trial treatment.
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Metformin IR
n=261 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period
|
23.8 percentage of subjects
Interval 18.72 to 29.39
|
22.3 percentage of subjects
Interval 17.47 to 27.86
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety population included all subjects who received at least 1 dose of trial treatment.
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.
Outcome measures
| Measure |
Metformin IR
n=261 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Diarrhoea
|
16.5 percentage of subjects
Interval 12.19 to 21.54
|
12.5 percentage of subjects
Interval 8.76 to 17.1
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Abdominal Distension
|
6.1 percentage of subjects
Interval 3.54 to 9.76
|
6.4 percentage of subjects
Interval 3.8 to 10.11
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Nausea
|
6.1 percentage of subjects
Interval 3.54 to 9.76
|
4.5 percentage of subjects
Interval 2.37 to 7.81
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Abdominal Pain
|
2.3 percentage of subjects
Interval 0.85 to 4.94
|
1.9 percentage of subjects
Interval 0.62 to 4.36
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Constipation
|
1.9 percentage of subjects
Interval 0.62 to 4.41
|
1.9 percentage of subjects
Interval 0.62 to 4.36
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Dyspepsia
|
1.1 percentage of subjects
Interval 0.24 to 3.32
|
0.8 percentage of subjects
Interval 0.09 to 2.71
|
|
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Flatulence
|
0.4 percentage of subjects
Interval 0.01 to 2.12
|
0 percentage of subjects
Interval 0.0 to 1.39
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 8, 12,16Population: ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. Here "n" signifies those subjects who were evaluable for the specified time points for each arm, respectively.
Outcome measures
| Measure |
Metformin IR
n=251 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=254 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Baseline (n=251, 254)
|
8.464 Millimole Per Liter (mmol/L)
Standard Deviation 1.7470
|
8.690 Millimole Per Liter (mmol/L)
Standard Deviation 2.0977
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 1 (n= 249, 248)
|
-0.647 Millimole Per Liter (mmol/L)
Standard Deviation 1.5615
|
-0.736 Millimole Per Liter (mmol/L)
Standard Deviation 1.4305
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 2 (n= 243, 244)
|
-1.324 Millimole Per Liter (mmol/L)
Standard Deviation 1.4426
|
-1.267 Millimole Per Liter (mmol/L)
Standard Deviation 1.9346
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 4 (n= 240, 239)
|
-1.558 Millimole Per Liter (mmol/L)
Standard Deviation 1.6245
|
-1.604 Millimole Per Liter (mmol/L)
Standard Deviation 1.7971
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 8 (n= 219, 230)
|
-2.075 Millimole Per Liter (mmol/L)
Standard Deviation 1.7359
|
-1.999 Millimole Per Liter (mmol/L)
Standard Deviation 2.0192
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 12 (n= 216, 221)
|
-2.053 Millimole Per Liter (mmol/L)
Standard Deviation 1.7599
|
-2.048 Millimole Per Liter (mmol/L)
Standard Deviation 1.8532
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Change at Week 16 (n= 214, 218)
|
-1.976 Millimole Per Liter (mmol/L)
Standard Deviation 1.7529
|
-2.183 Millimole Per Liter (mmol/L)
Standard Deviation 1.8481
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and 16Population: ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. Here "n" signifies those subjects who were evaluable for the specified time points for each arm, respectively.
The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.
Outcome measures
| Measure |
Metformin IR
n=223 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=231 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16
Baseline (n= 223, 231)
|
14.604 mmol/L
Standard Deviation 3.4334
|
14.764 mmol/L
Standard Deviation 3.7705
|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16
Change at Week 8 (n= 215, 229)
|
-3.608 mmol/L
Standard Deviation 3.6964
|
-3.264 mmol/L
Standard Deviation 5.9134
|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16
Change at Week 16 (n= 213, 215)
|
-3.642 mmol/L
Standard Deviation 3.7261
|
-3.693 mmol/L
Standard Deviation 3.5414
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety population included all subjects who received at least 1 dose of trial treatment.
Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter \[mmol/L\]).
Outcome measures
| Measure |
Metformin IR
n=261 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects With Hypoglycemia
|
1.1 percentage of subjects
Interval 0.24 to 3.32
|
3.0 percentage of subjects
Interval 1.32 to 5.88
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.
Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.
Outcome measures
| Measure |
Metformin IR
n=267 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=265 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects With Marked Hyperglycemia
|
0.7 percentage of subjects
Interval 0.09 to 2.68
|
2.3 percentage of subjects
Interval 0.84 to 4.86
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.
Outcome measures
| Measure |
Metformin IR
n=267 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=265 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects With HbA1c Less Than (<) 7%
|
68.5 percentage of subjects
Interval 62.6 to 74.06
|
69.8 percentage of subjects
Interval 63.9 to 75.28
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety population included all subjects who received at least 1 dose of trial treatment.
Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.
Outcome measures
| Measure |
Metformin IR
n=261 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects Who Are Totally Intolerant to the Treatment
|
7.3 percentage of subjects
Interval 4.44 to 11.13
|
5.7 percentage of subjects
Interval 3.21 to 9.2
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.
Percentage of subjects with HbA1c \<7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
Outcome measures
| Measure |
Metformin IR
n=267 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=265 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)
|
68.2 percentage of subjects
Interval 62.21 to 73.71
|
69.8 percentage of subjects
Interval 63.9 to 75.28
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: The safety population included all subjects who received at least 1 dose of trial treatment.
Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.
Outcome measures
| Measure |
Metformin IR
n=261 Participants
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 Participants
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
|---|---|---|
|
Percentage of Subjects Who Are Compliant to Treatment
|
99.2 percentage of subjects
|
99.2 percentage of subjects
|
Adverse Events
Metformin IR
Serious events: 6 serious events
Other events: 96 other events
Deaths: 0 deaths
Metformin XR
Serious events: 2 serious events
Other events: 136 other events
Deaths: 0 deaths
Metformin IR to XR
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin IR
n=249 participants at risk
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 participants at risk
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
Metformin IR to XR
n=12 participants at risk
Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Eye disorders
Retinal detachment
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood ketone body increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
Other adverse events
| Measure |
Metformin IR
n=249 participants at risk
Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
|
Metformin XR
n=264 participants at risk
Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
|
Metformin IR to XR
n=12 participants at risk
Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Cardiac Discomfort
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Palpitations
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Right Ventricular Hypertrophy
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Cardiac disorders
Tachycardia
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Ear and labyrinth disorders
Inner Ear Disorder
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Eye disorders
Cataract
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Eye disorders
Eye Ulcer
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Eye disorders
Visual Acuity Reduced
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.6%
4/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.4%
9/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
6.4%
16/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
6.4%
17/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
5/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.4%
6/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.4%
9/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Abnormal Faeces
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.1%
3/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Bowel Movement Irregularity
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
5/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
34/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
12.5%
33/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
75.0%
9/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Faeces Hard
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.4%
9/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.6%
4/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.5%
4/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
14/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
4.5%
12/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
25.0%
3/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
4/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Asthenia
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Chest Disconfort
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Chest pain
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Fatigue
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Hangover
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
2.0%
5/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.0%
8/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Hepatobiliary disorders
Periphatic Discomfort
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Immune system disorders
Drug Hypersensitivity
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Chronic Hepatitis B
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.0%
5/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.5%
4/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Infections and infestations
Urinary tract Infection
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.4%
9/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.1%
3/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Bilirubin increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Glucose Decreased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood pressure Decreased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Sodium Increased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood Triglycerides Increased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Blood uric Acid Increased
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Electrocardiogram ST Segment Depression
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Electrocardiogram ST Segment Elevation
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Electrocardiogram T Wave Amplitude Decreased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Gastric PH Decreased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Low Density Lipoprotein Increased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Platelet Count Decreased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Protein Urine Present
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Urine Ketone Body Present
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
Weight Decreased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
White Blood Cell Count Decreased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.4%
6/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.5%
4/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.9%
5/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
3/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
3.0%
8/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.1%
3/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
25.0%
3/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Dizziness
|
2.8%
7/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
4.2%
11/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Head Discomfort
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Headache
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
1.5%
4/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
8.3%
1/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Psychiatric disorders
Initial Insomnia
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Psychiatric disorders
Libido Decreased
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Psychiatric disorders
Listless
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Renal and urinary disorders
Renal Cyst
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Reproductive system and breast disorders
Prostatic Calcification
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.38%
1/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Generalized Erythema
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.80%
2/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Pigmentation Disorder
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
|
Vascular disorders
Hypertension
|
0.40%
1/249 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.76%
2/264 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
0.00%
0/12 • Baseline up to Week 18
Serious adverse events (SAEs) and Non-SAEs were presented separately for subjects who switched from Metformin IR to Metformin XR group due to intolerance to Metformin IR treatment.
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place