Trial Outcomes & Findings for Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control (NCT NCT00283049)
NCT ID: NCT00283049
Last Updated: 2011-01-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
390 participants
Primary outcome timeframe
12 weeks from Baseline
Results posted on
2011-01-13
Participant Flow
Participant milestones
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
128
|
130
|
|
Overall Study
COMPLETED
|
70
|
83
|
76
|
|
Overall Study
NOT COMPLETED
|
58
|
45
|
54
|
Reasons for withdrawal
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
4
|
|
Overall Study
Protocol Violation
|
3
|
0
|
3
|
|
Overall Study
Death
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
26
|
24
|
19
|
|
Overall Study
Discontinuation of Study
|
18
|
16
|
20
|
|
Overall Study
No longer requires study treatment
|
0
|
0
|
1
|
Baseline Characteristics
Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control
Baseline characteristics by cohort
| Measure |
SU + TZD + IG
n=128 Participants
Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c \>6.5%)
|
MET + TZD + IG
n=128 Participants
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c \>6.5%)
|
MET+SU + IG
n=130 Participants
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c \>6.5%)
|
Total
n=386 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 9.57 • n=93 Participants
|
54.7 years
STANDARD_DEVIATION 10.14 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 9.41 • n=27 Participants
|
55.2 years
STANDARD_DEVIATION 9.71 • n=483 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
157 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
229 Participants
n=483 Participants
|
|
Region of Enrollment
USA
|
128 participants
n=93 Participants
|
128 participants
n=4 Participants
|
130 participants
n=27 Participants
|
386 participants
n=483 Participants
|
|
Body Mass Index (BMI)
|
33.2 kg/m²
STANDARD_DEVIATION 6.41 • n=93 Participants
|
34.3 kg/m²
STANDARD_DEVIATION 6.57 • n=4 Participants
|
34.5 kg/m²
STANDARD_DEVIATION 7.04 • n=27 Participants
|
34.0 kg/m²
STANDARD_DEVIATION 6.69 • n=483 Participants
|
|
Duration of diabetes
|
10.5 years
STANDARD_DEVIATION 6.95 • n=93 Participants
|
9.7 years
STANDARD_DEVIATION 5.68 • n=4 Participants
|
10.5 years
STANDARD_DEVIATION 6.00 • n=27 Participants
|
10.2 years
STANDARD_DEVIATION 6.23 • n=483 Participants
|
|
Weight
|
98.1 kg
STANDARD_DEVIATION 21.46 • n=93 Participants
|
99.6 kg
STANDARD_DEVIATION 20.22 • n=4 Participants
|
101.2 kg
STANDARD_DEVIATION 24.98 • n=27 Participants
|
99.6 kg
STANDARD_DEVIATION 22.31 • n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from BaselinePopulation: Safety Population (excluding patients from Good Clinical Practice \[GCP\] non-compliant sites)
Outcome measures
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
n=116 Participants
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
n=111 Participants
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
n=120 Participants
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
|
-1.2 Percentage
Standard Deviation 1.72
|
-1.2 Percentage
Standard Deviation 1.35
|
-1.2 Percentage
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 60 weeks from BaselinePopulation: The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 weeks from BaselinePopulation: The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 weeks from BaselinePopulation: The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 weeks from BaselinePopulation: The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 weeks from BaselinePopulation: Safety Population
* Symptomatic hypoglycemia (BG\<70 mg/dL, BG\<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling. * Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but \<70 mg/dL * Severe hypoglycemia: assistance of another party is required \& either: * SMBG of \<36 mg/dL, or * with prompt response to treatment with oral carbohydrates, IV glucose or glucagon. * Serious hypoglycemia: * Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Outcome measures
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
n=128 Participants
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
n=128 Participants
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
n=130 Participants
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Any reported symptomatic Hypoglycemic event
|
110 Participants
|
107 Participants
|
112 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Symptomatic events with Self-monitored BG (SMBG)
|
109 Participants
|
106 Participants
|
112 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
SMBG <70 mg/dL with symptom
|
107 Participants
|
102 Participants
|
112 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
SMBG <50mg/dL with symptom
|
74 Participants
|
71 Participants
|
85 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
SMBG <36 mg/dL with symptom
|
23 Participants
|
24 Participants
|
35 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Severe Hypoglycemias
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Severe only due to SMBG <36mg/dL
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Severe: Prompt response to CHO countermeasure
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Severe:SMBG<36mg/dL, prompt response to CHO
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Serious hypoglycemia
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Coma/Loss of Consciousness
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 Weeks from BaselinePopulation: Safety Population
* Symptomatic hypoglycemia (BG\<70 mg/dL, BG\<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling. * Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but \<70 mg/dL * Severe hypoglycemia: assistance of another party is required \& either: * SMBG of \<36 mg/dL, or * with prompt response to treatment with oral carbohydrates, IV glucose or glucagon. * Serious hypoglycemia: * Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Outcome measures
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
n=128 Participants
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
n=128 Participants
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
n=130 Participants
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Exposure (Patient-years)
|
0.941 events/ patient-year
Standard Deviation 0.3285
|
0.943 events/ patient-year
Standard Deviation 0.3692
|
0.967 events/ patient-year
Standard Deviation 0.3118
|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Hypoglycemic (HE) event with SMBG <70mg/dL
|
30.1 events/ patient-year
Standard Deviation 35.54
|
16.5 events/ patient-year
Standard Deviation 20.35
|
25.3 events/ patient-year
Standard Deviation 26.81
|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
HE with SMBG <50mg/dL
|
4.9 events/ patient-year
Standard Deviation 7.48
|
3.3 events/ patient-year
Standard Deviation 5.74
|
5.6 events/ patient-year
Standard Deviation 8.17
|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
HE with SMBG <36mg/dL
|
0.3 events/ patient-year
Standard Deviation 0.87
|
0.3 events/ patient-year
Standard Deviation 0.76
|
0.6 events/ patient-year
Standard Deviation 1.55
|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Severe HE (BG<36mg/dL or prompt response to CHO
|
0.1 events/ patient-year
Standard Deviation 0.31
|
0.1 events/ patient-year
Standard Deviation 0.53
|
0.1 events/ patient-year
Standard Deviation 0.30
|
|
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Serious HE (coma/loss of consciousness,seizure)
|
0.0 events/ patient-year
Standard Deviation 0.14
|
0.0 events/ patient-year
Standard Deviation 0.09
|
0.0 events/ patient-year
Standard Deviation 0.00
|
Adverse Events
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
Serious events: 22 serious events
Other events: 99 other events
Deaths: 0 deaths
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
Serious events: 20 serious events
Other events: 84 other events
Deaths: 0 deaths
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Serious events: 13 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
n=128 participants at risk
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
n=128 participants at risk
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
n=130 participants at risk
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/128
|
0.00%
0/128
|
1.5%
2/130
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Cardiac disorders
Coronary artery disease
|
2.3%
3/128
|
1.6%
2/128
|
0.77%
1/130
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/128
|
0.78%
1/128
|
0.77%
1/130
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
General disorders
Chest Discomfort
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Infections and infestations
Appendicitis
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Infections and infestations
Bronchitis
|
1.6%
2/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Infections and infestations
Bronchopneumonia
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Infections and infestations
Cellulitis
|
0.78%
1/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Infections and infestations
Gastroenteritis
|
0.78%
1/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Infections and infestations
Pneumonia
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Infections and infestations
Scrotal abscess
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Injury, poisoning and procedural complications
Overdose
|
1.6%
2/128
|
3.9%
5/128
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.78%
1/128
|
1.6%
2/128
|
0.00%
0/130
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.78%
1/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Nervous system disorders
Convulsion
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Nervous system disorders
Hypoglycaemic coma
|
1.6%
2/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.78%
1/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.78%
1/128
|
0.00%
0/128
|
0.00%
0/130
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/128
|
0.00%
0/128
|
0.77%
1/130
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/128
|
0.78%
1/128
|
0.00%
0/130
|
Other adverse events
| Measure |
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)
n=128 participants at risk
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)
n=128 participants at risk
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
n=130 participants at risk
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.6%
11/128
|
9.4%
12/128
|
10.8%
14/130
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
9/128
|
13.3%
17/128
|
6.9%
9/130
|
|
Infections and infestations
Bronchitis
|
8.6%
11/128
|
5.5%
7/128
|
4.6%
6/130
|
|
Infections and infestations
Influenza
|
4.7%
6/128
|
5.5%
7/128
|
5.4%
7/130
|
|
Infections and infestations
Sinusitis
|
5.5%
7/128
|
5.5%
7/128
|
4.6%
6/130
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
9/128
|
4.7%
6/128
|
5.4%
7/130
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
10/128
|
3.1%
4/128
|
3.1%
4/130
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
4/128
|
4.7%
6/128
|
5.4%
7/130
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.7%
6/128
|
5.5%
7/128
|
3.8%
5/130
|
|
Investigations
Weight increased
|
6.2%
8/128
|
2.3%
3/128
|
0.77%
1/130
|
|
General disorders
Edema Peripheral
|
12.5%
16/128
|
4.7%
6/128
|
8.5%
11/130
|
|
Vascular disorders
Hypertension
|
3.1%
4/128
|
1.6%
2/128
|
5.4%
7/130
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER