Trial Outcomes & Findings for Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus (NCT NCT02024971)
NCT ID: NCT02024971
Last Updated: 2016-11-22
Results Overview
Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Recruitment status
COMPLETED
Target enrollment
1103 participants
Primary outcome timeframe
12 months
Results posted on
2016-11-22
Participant Flow
Participants took part in the study at 196 investigative sites in Japan from July 2010 to November 2013 (N=1103).
Patients with type 2 diabetes mellitus for whom a physician has concluded that therapy with pioglitazone hydrochloride combined with metformin hydrochloride is suitable and for whom long-term treatment with Metact Combination Tablets is considered necessary.
Participant milestones
| Measure |
Pioglitazone/Metformin Hydrochloride
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Overall Study
STARTED
|
1103
|
|
Overall Study
Safety Analysis Set
|
1067
|
|
Overall Study
COMPLETED
|
1067
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Pioglitazone/Metformin Hydrochloride
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Overall Study
Data Not Available
|
30
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Pioglitazone/Metformin Hydrochloride
n=1067 Participants
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 12.01 • n=93 Participants
|
|
Age, Customized
<65 years
|
534 participants
n=93 Participants
|
|
Age, Customized
≥65 years
|
533 participants
n=93 Participants
|
|
Age, Customized
<20 years
|
0 participants
n=93 Participants
|
|
Age, Customized
≥20 to <30 years
|
7 participants
n=93 Participants
|
|
Age, Customized
≥30 to <40 years
|
33 participants
n=93 Participants
|
|
Age, Customized
≥40 to <50 years
|
91 participants
n=93 Participants
|
|
Age, Customized
≥50 to <60 years
|
218 participants
n=93 Participants
|
|
Age, Customized
≥60 to <70 years
|
347 participants
n=93 Participants
|
|
Age, Customized
≥70 to <80 years
|
294 participants
n=93 Participants
|
|
Age, Customized
≥80 years
|
77 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
450 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
617 Participants
n=93 Participants
|
|
Pregnancy status (Females)
Not pregnant
|
450 participants
n=93 Participants
|
|
Pregnancy status (Females)
Pregnant
|
0 participants
n=93 Participants
|
|
Weight
|
69.0 kg
STANDARD_DEVIATION 15.36 • n=93 Participants
|
|
Weight, Customized
<40 kg
|
7 participants
n=93 Participants
|
|
Weight, Customized
≥40 to <50 kg
|
48 participants
n=93 Participants
|
|
Weight, Customized
≥50 to <60 kg
|
138 participants
n=93 Participants
|
|
Weight, Customized
≥60 to <70 kg
|
193 participants
n=93 Participants
|
|
Weight, Customized
≥70 kg
|
310 participants
n=93 Participants
|
|
Weight, Customized
Unmeasured
|
371 participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
26.61 kg/m^2
STANDARD_DEVIATION 4.738 • n=93 Participants
|
|
Body Mass Index, Customized
<18.5 kg/m^2
|
10 participants
n=93 Participants
|
|
Body Mass Index, Customized
≥18.5 to <25 kg/m^2
|
261 participants
n=93 Participants
|
|
Body Mass Index, Customized
≥25 to <30 kg/m^2
|
280 participants
n=93 Participants
|
|
Body Mass Index, Customized
≥30 kg/m^2
|
125 participants
n=93 Participants
|
|
Body Mass Index, Customized
Unknown
|
391 participants
n=93 Participants
|
|
Duration of Type 2 Diabetes
|
7.5 years
STANDARD_DEVIATION 6.59 • n=93 Participants
|
|
Duration of Type 2 Diabetes, Customized
<2 years
|
163 participants
n=93 Participants
|
|
Duration of Type 2 Diabetes, Customized
≥2 to <5 years
|
168 participants
n=93 Participants
|
|
Duration of Type 2 Diabetes, Customized
≥5 to <10 years
|
183 participants
n=93 Participants
|
|
Duration of Type 2 Diabetes, Customized
≥10 years
|
216 participants
n=93 Participants
|
|
Duration of Type 2 Diabetes, Customized
Unknown
|
337 participants
n=93 Participants
|
|
Healthcare Category
Outpatient
|
1049 participants
n=93 Participants
|
|
Healthcare Category
Inpatient
|
6 participants
n=93 Participants
|
|
Healthcare Category
Outpatient and Inpatient
|
12 participants
n=93 Participants
|
|
History of Allergies
No
|
931 participants
n=93 Participants
|
|
History of Allergies
Yes
|
95 participants
n=93 Participants
|
|
History of Allergies
Unknown
|
41 participants
n=93 Participants
|
|
Presence of Complications
No
|
132 participants
n=93 Participants
|
|
Presence of Complications
Yes
|
935 participants
n=93 Participants
|
|
Breakdown of Complications
Diabetic complications
|
169 participants
n=93 Participants
|
|
Breakdown of Complications
Lifestyle-related diseases (excluding DM)
|
858 participants
n=93 Participants
|
|
Breakdown of Complications
Liver diseases
|
139 participants
n=93 Participants
|
|
Breakdown of Complications
Renal diseases
|
9 participants
n=93 Participants
|
|
Breakdown of Complications
Heart or cerebrovascular diseases
|
144 participants
n=93 Participants
|
|
Breakdown of Complications
Allergic conditions
|
84 participants
n=93 Participants
|
|
Breakdown of Complications
Malignant tumors
|
10 participants
n=93 Participants
|
|
Breakdown of Complications
Other
|
349 participants
n=93 Participants
|
|
Complications: Breakdown of Diabetic Complications
Diabetic nephropathy
|
81 participants
n=93 Participants
|
|
Complications: Breakdown of Diabetic Complications
Diabetic retinopathy
|
56 participants
n=93 Participants
|
|
Complications: Breakdown of Diabetic Complications
Diabetic neuropathy
|
74 participants
n=93 Participants
|
|
Complications: Breakdown of Lifestyle-Related Diseases (Excluding Diabetes Mellitus)
Hypertension
|
656 participants
n=93 Participants
|
|
Complications: Breakdown of Lifestyle-Related Diseases (Excluding Diabetes Mellitus)
Dyslipidaemia
|
634 participants
n=93 Participants
|
|
Complications: Breakdown of Lifestyle-Related Diseases (Excluding Diabetes Mellitus)
Hyperuricaemia
|
79 participants
n=93 Participants
|
|
Complications: Breakdown of Liver Diseases
Hepatic steatosis
|
107 participants
n=93 Participants
|
|
Complications: Breakdown of Liver Diseases
Hepatitis alcoholic
|
14 participants
n=93 Participants
|
|
Complications: Breakdown of Liver Diseases
Chronic hepatitis
|
17 participants
n=93 Participants
|
|
Complications: Breakdown of Liver Diseases
Hepatic cirrhosis
|
1 participants
n=93 Participants
|
|
Complications: Breakdown of Renal Diseases
Nephrotic syndrome
|
2 participants
n=93 Participants
|
|
Complications: Breakdown of Renal Diseases
Renal failure chronic
|
4 participants
n=93 Participants
|
|
Complications: Breakdown of Heart or Cerebrovascular Diseases
Cardiac failure
|
17 participants
n=93 Participants
|
|
Complications: Breakdown of Heart or Cerebrovascular Diseases
Myocardial infarction
|
9 participants
n=93 Participants
|
|
Complications: Breakdown of Heart or Cerebrovascular Diseases
Angina pectoris
|
55 participants
n=93 Participants
|
|
Complications: Breakdown of Heart or Cerebrovascular Diseases
Cerebral infarction (including late effects)
|
52 participants
n=93 Participants
|
|
Stages of Cardiac Failure (New York Heart Association [NYHA] Classification)
Class I
|
14 participants
n=93 Participants
|
|
Stages of Cardiac Failure (New York Heart Association [NYHA] Classification)
Class II
|
3 participants
n=93 Participants
|
|
Stages of Cardiac Failure (New York Heart Association [NYHA] Classification)
Class III
|
0 participants
n=93 Participants
|
|
Stages of Cardiac Failure (New York Heart Association [NYHA] Classification)
Class IV
|
0 participants
n=93 Participants
|
|
Complications: Breakdown of Allergic Conditions
Asthma bronchial
|
33 participants
n=93 Participants
|
|
Complications: Breakdown of Allergic Conditions
Pollinosis
|
12 participants
n=93 Participants
|
|
Complications: Breakdown of Allergic Conditions
Rhinitis allergic
|
38 participants
n=93 Participants
|
|
Complications: Breakdown of Allergic Conditions
Dermatitis allergic
|
11 participants
n=93 Participants
|
|
Complications: Breakdown of Malignant Tumors
Gastric cancer
|
1 participants
n=93 Participants
|
|
Complications: Breakdown of Malignant Tumors
Large intestine carcinoma
|
4 participants
n=93 Participants
|
|
Presence of Medical History
No
|
875 participants
n=93 Participants
|
|
Presence of Medical History
Yes
|
143 participants
n=93 Participants
|
|
Presence of Medical History
Unknown
|
49 participants
n=93 Participants
|
|
Alcohol History (Drinking Alcohol-Containing Beverages Nearly Every Day)
No
|
597 participants
n=93 Participants
|
|
Alcohol History (Drinking Alcohol-Containing Beverages Nearly Every Day)
Yes
|
293 participants
n=93 Participants
|
|
Alcohol History (Drinking Alcohol-Containing Beverages Nearly Every Day)
Unknown
|
177 participants
n=93 Participants
|
|
Smoking Classification
Never smoked
|
499 participants
n=93 Participants
|
|
Smoking Classification
Current smoker
|
155 participants
n=93 Participants
|
|
Smoking Classification
Ex-smoker
|
196 participants
n=93 Participants
|
|
Smoking Classification
Unknown
|
217 participants
n=93 Participants
|
|
Status of Administration of Pioglitazone and Metformin Prior to Dosing of Metact Combination Tablets
Pioglitazone plus metformin prior to dosing
|
277 participants
n=93 Participants
|
|
Status of Administration of Pioglitazone and Metformin Prior to Dosing of Metact Combination Tablets
Pioglitazone alone prior to dosing
|
442 participants
n=93 Participants
|
|
Status of Administration of Pioglitazone and Metformin Prior to Dosing of Metact Combination Tablets
Metformin alone prior to dosing
|
211 participants
n=93 Participants
|
|
Status of Administration of Pioglitazone and Metformin Prior to Dosing of Metact Combination Tablets
Neither pioglitazone nor metformin prior to dosing
|
137 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Prior to Dosing of Metact Combination Tablets
|
20.5 mg/day
STANDARD_DEVIATION 7.60 • n=93 Participants
|
|
Daily Dose of Pioglitazone Prior to Dosing of Metact Combination Tablets
≤ 15 mg/day
|
456 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Prior to Dosing of Metact Combination Tablets
> 15 to ≤ 30 mg/day
|
258 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Prior to Dosing of Metact Combination Tablets
> 30 to ≤ 45 mg/day
|
5 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Prior to Dosing of Metact Combination Tablets
> 45 mg/day
|
0 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≤15 mg/day of Pio to Metact LD
|
429 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≤15 mg/day of Pio to Metact HD
|
27 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>15 to ≤30 mg/day of Pio to Metact LD
|
46 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>15 to ≤30 mg/day of Pio to Metact HD
|
212 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>30 to ≤45 mg/day of Pio to Metact LD
|
1 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>30 to ≤45 mg/day of Pio to Metact HD
|
4 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>45 mg/day of Pio to Metact LD
|
0 participants
n=93 Participants
|
|
Daily Dose of Pioglitazone Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>45 mg/day of Pio to Metact HD
|
0 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
|
681.4 mg/day
STANDARD_DEVIATION 310.08 • n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
< 500 mg/day
|
25 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
≥ 500 to < 750 mg/day
|
229 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
≥ 750 to < 1500 mg/day
|
206 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
≥ 1500 to < 2250 mg/day
|
22 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
≥ 2250 mg/day
|
6 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
≤ 500 mg/day
|
254 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
> 500 to ≤ 750 mg/day
|
163 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
> 750 mg/day
|
71 participants
n=93 Participants
|
|
Daily Dose of Metformin Prior to Dosing of Metact Combination Tablets
> 500 mg/day
|
234 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
<500 mg/day of Met to Metact LD
|
19 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
<500 mg/day of Met to Metact HD
|
6 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥500 to <750 mg/day of Met to Metact LD
|
174 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥500 to <750 mg/day of Met to Metact HD
|
55 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥750 to <1500 mg/day of Met to Metact LD
|
155 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥750 to <1500 mg/day of Met to Metact HD
|
49 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥1500 to <2250 mg/day of Met to Metact LD
|
12 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥1500 to <2250 mg/day of Met to Metact HD
|
10 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥2250 mg/day of Met to Metact LD
|
2 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≥2250 mg/day of Met to Metact HD
|
4 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≤500 mg/day of Met to Metact LD
|
193 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
≤500 mg/day of Met to Metact HD
|
61 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>500 to ≤750 mg/day of Met to Metact LD
|
124 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>500 to ≤750 mg/day of Met to Metact HD
|
37 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>750 mg/day of Met to Metact LD
|
45 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
>750 mg/day of Met to Metact HD
|
26 participants
n=93 Participants
|
|
Daily Dose of Metformin Before Switching to Metact Combination Tablets,and Metact Dose Assignment
Other
|
2 participants
n=93 Participants
|
|
Compliance Status of Pioglitazone (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 90%
|
534 participants
n=93 Participants
|
|
Compliance Status of Pioglitazone (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 70%
|
142 participants
n=93 Participants
|
|
Compliance Status of Pioglitazone (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 50%
|
19 participants
n=93 Participants
|
|
Compliance Status of Pioglitazone (Within 3 Months Before Switching to Metact Combination Tablets)
< 50%
|
6 participants
n=93 Participants
|
|
Compliance Status of Pioglitazone (Within 3 Months Before Switching to Metact Combination Tablets)
Unknown
|
18 participants
n=93 Participants
|
|
Compliance Status of Metformin (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 90%
|
380 participants
n=93 Participants
|
|
Compliance Status of Metformin (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 70%
|
75 participants
n=93 Participants
|
|
Compliance Status of Metformin (Within 3 Months Before Switching to Metact Combination Tablets)
≥ 50%
|
22 participants
n=93 Participants
|
|
Compliance Status of Metformin (Within 3 Months Before Switching to Metact Combination Tablets)
< 50%
|
8 participants
n=93 Participants
|
|
Compliance Status of Metformin (Within 3 Months Before Switching to Metact Combination Tablets)
Unknown
|
3 participants
n=93 Participants
|
|
Frequency of daily dosing of Metformin prior to dosing of Metact Combination Tablets
Daily
|
58 participants
n=93 Participants
|
|
Frequency of daily dosing of Metformin prior to dosing of Metact Combination Tablets
BID
|
246 participants
n=93 Participants
|
|
Frequency of daily dosing of Metformin prior to dosing of Metact Combination Tablets
TID or more
|
184 participants
n=93 Participants
|
|
Switch from metformin (> 500 mg/day) to Metact Combination Tablets
No
|
833 participants
n=93 Participants
|
|
Switch from metformin (> 500 mg/day) to Metact Combination Tablets
Yes
|
234 participants
n=93 Participants
|
|
Response to pioglitazone in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
Inadequate responders
|
307 participants
7.60 • n=93 Participants
|
|
Response to pioglitazone in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
Patients excluding inadequate responders
|
74 participants
n=93 Participants
|
|
Response to pioglitazone in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
Unknown
|
61 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
|
20.7 mg/day
STANDARD_DEVIATION 7.60 • n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
≤ 15 mg/day
|
191 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
> 15 mg/day to ≤ 30 mg/day
|
114 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
> 30 mg/day to ≤ 45 mg/day
|
2 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to dosing of Metact Combination Tablets
> 45 mg/day
|
0 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
≤ 15 mg/day of Pio to Metact LD
|
178 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
≤ 15 mg/day of Pio to Metact HD
|
13 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 15 mg/day to ≤ 30 mg/day of Pio to Metact LD
|
21 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 15 mg/day to ≤ 30 mg/day of Pio to Metact HD
|
93 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 30 mg/day to ≤ 45 mg/day of Pio to Metact LD
|
0 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 30 mg/day to ≤ 45 mg/day of Pio to Metact HD
|
2 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 45 mg/day of Pio to Metact LD
|
0 participants
n=93 Participants
|
|
Daily dose in Pioglitazone monotherapy prior to switching to Metact Combination Tablets
> 45 mg/day of Pio to Metact HD
|
0 participants
n=93 Participants
|
|
Rate of compliance with the diet regimen at the start of treatment with Metact Combination Tablets
≥ 90%
|
270 participants
n=93 Participants
|
|
Rate of compliance with the diet regimen at the start of treatment with Metact Combination Tablets
≥ 70%
|
367 participants
n=93 Participants
|
|
Rate of compliance with the diet regimen at the start of treatment with Metact Combination Tablets
≥ 50%
|
259 participants
n=93 Participants
|
|
Rate of compliance with the diet regimen at the start of treatment with Metact Combination Tablets
< 50%
|
76 participants
n=93 Participants
|
|
Rate of compliance with the diet regimen at the start of treatment with Metact Combination Tablets
Not assessed or compliance status is unknown
|
95 participants
n=93 Participants
|
|
Rate of compliance with exercise regimen at the start of treatment with Metact Combination Tablets
≥ 90%
|
205 participants
n=93 Participants
|
|
Rate of compliance with exercise regimen at the start of treatment with Metact Combination Tablets
≥ 70%
|
294 participants
n=93 Participants
|
|
Rate of compliance with exercise regimen at the start of treatment with Metact Combination Tablets
≥ 50%
|
305 participants
n=93 Participants
|
|
Rate of compliance with exercise regimen at the start of treatment with Metact Combination Tablets
< 50%
|
135 participants
n=93 Participants
|
|
Rate of compliance with exercise regimen at the start of treatment with Metact Combination Tablets
Not assessed or compliance status is unknown
|
128 participants
n=93 Participants
|
|
HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
|
7.69 percentage of HbA1c
STANDARD_DEVIATION 1.369 • n=93 Participants
|
|
Participants with HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
< 6.0%
|
39 participants
n=93 Participants
|
|
Participants with HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
≥ 6.0% to < 7.0%
|
270 participants
n=93 Participants
|
|
Participants with HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
≥ 7.0% to < 8.0%
|
340 participants
n=93 Participants
|
|
Participants with HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
≥ 8.0%
|
290 participants
n=93 Participants
|
|
Participants with HbA1c (NGSP value) at the start of treatment with Metact Combination Tablets
Unknown
|
128 participants
n=93 Participants
|
|
Fasting blood glucose at the start of treatment with Metact Combination Tablets
|
150.1 mg/dL
STANDARD_DEVIATION 56.43 • n=93 Participants
|
|
Participants with Fasting blood glucose at the start of treatment with Metact Combination Tablets
< 126 mg/dL
|
157 participants
n=93 Participants
|
|
Participants with Fasting blood glucose at the start of treatment with Metact Combination Tablets
≥ 126 to < 140 mg/dL
|
75 participants
n=93 Participants
|
|
Participants with Fasting blood glucose at the start of treatment with Metact Combination Tablets
≥ 140 to < 160 mg/dL
|
80 participants
n=93 Participants
|
|
Participants with Fasting blood glucose at the start of treatment with Metact Combination Tablets
≥ 160 mg/dL
|
134 participants
n=93 Participants
|
|
Participants with Fasting blood glucose at the start of treatment with Metact Combination Tablets
Unknown
|
621 participants
n=93 Participants
|
|
Fasting insulin at the start of treatment with Metact Combination Tablets
|
10.775 μU/dL
STANDARD_DEVIATION 9.0804 • n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
< 1.0 μU/dL
|
0 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
≥ 1.0 μU/dL to < 5.0 μU/dL
|
24 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
≥ 5.0 μU/dL to < 10.0 μU/dL
|
25 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
≥ 10.0 μU/dL to < 50.0 μU/dL
|
46 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
≥ 50.0 μU/dL to < 100.0 μU/dL
|
1 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
≥ 100 μU/dL
|
0 participants
n=93 Participants
|
|
Participants with Fasting insulin at the start of treatment with Metact Combination Tablets
Unknown
|
971 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety Analysis Set, all patients for whom data was collected in case report forms, except those who were treated before the contract period, those who were enrolled after Day 15 of the start of treatment with Metact Combination Tablets, and those with missing data after treatment (missed visits).
Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Pioglitazone/Metformin Hydrochloride
n=1067 Participants
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions
Thyroid cancer
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Anaemia
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Insomnia
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Dizziness
|
2 participants
|
|
Number of Participants With Adverse Drug Reactions
Dysgeusia
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Right ventricular failure
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Dyspnoea exertional
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Abdominal distension
|
2 participants
|
|
Number of Participants With Adverse Drug Reactions
Constipation
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Nausea
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Hepatic function abnormal
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Cold sweat
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Myalgia
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Renal impairment
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Chest discomfort
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Face oedema
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Malaise
|
2 participants
|
|
Number of Participants With Adverse Drug Reactions
Oedema
|
5 participants
|
|
Number of Participants With Adverse Drug Reactions
Oedema peripheral
|
11 participants
|
|
Number of Participants With Adverse Drug Reactions
Cardiothoracic ratio increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Blood cholesterol increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Blood triglycerides increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Lipids abnormal
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Blood creatinine increased
|
1 participants
|
|
Number of Participants With Adverse Drug Reactions
Weight increased
|
4 participants
|
|
Number of Participants With Adverse Drug Reactions
Heat illness
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12 and final assessmentPopulation: The analysis was performed in the efficacy assessment population (n=905).
Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Outcome measures
| Measure |
Pioglitazone/Metformin Hydrochloride
n=905 Participants
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 3 (n=819)
|
-0.47 percentage of HbA1c
Standard Deviation 1.030
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 6 (n=761)
|
-0.53 percentage of HbA1c
Standard Deviation 1.142
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 9 (n=681)
|
-0.55 percentage of HbA1c
Standard Deviation 1.183
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 12 (n=670)
|
-0.60 percentage of HbA1c
Standard Deviation 1.190
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Final Assessment (n=896)
|
-0.58 percentage of HbA1c
Standard Deviation 1.182
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12 and final assessmentPopulation: The analysis was performed in the efficacy assessment population (n=905).
Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Outcome measures
| Measure |
Pioglitazone/Metformin Hydrochloride
n=905 Participants
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Change From Baseline in Fasting Blood Glucose
Month 3 (n=311)
|
-14.0 mg/dL
Standard Deviation 41.98
|
|
Change From Baseline in Fasting Blood Glucose
Month 6 (n=275)
|
-15.5 mg/dL
Standard Deviation 40.82
|
|
Change From Baseline in Fasting Blood Glucose
Month 9 (n=29)
|
-11.7 mg/dL
Standard Deviation 43.16
|
|
Change From Baseline in Fasting Blood Glucose
Month 12 (n=255)
|
-17.3 mg/dL
Standard Deviation 42.97
|
|
Change From Baseline in Fasting Blood Glucose
Final Assessment (n=375)
|
-17.9 mg/dL
Standard Deviation 45.36
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12 and final assessmentPopulation: The analysis was performed in the efficacy assessment population (n=905).
Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.
Outcome measures
| Measure |
Pioglitazone/Metformin Hydrochloride
n=905 Participants
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Change From Baseline in Fasting Insulin
Month 3 (n=22)
|
-1.768 μU/dL
Standard Deviation 4.2928
|
|
Change From Baseline in Fasting Insulin
Month 6 (n=46)
|
-2.374 μU/dL
Standard Deviation 7.0954
|
|
Change From Baseline in Fasting Insulin
Month 9 (n=22)
|
-1.018 μU/dL
Standard Deviation 5.9072
|
|
Change From Baseline in Fasting Insulin
Month 12 (n=51)
|
-2.524 μU/dL
Standard Deviation 9.4260
|
|
Change From Baseline in Fasting Insulin
Final Assessment (n=63)
|
-2.107 μU/dL
Standard Deviation 8.7360
|
Adverse Events
Pioglitazone/Metformin Hydrochloride
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone/Metformin Hydrochloride
n=1067 participants at risk
Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.19%
2/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
3/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Hepatobiliary disorders
Liver disorder
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Renal and urinary disorders
Renal failure acute
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
General disorders
Sudden death
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.09%
1/1067 • From baseline to 12 months of treatment.
At each visit the investigator documented occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. The same PTs (Preferred Term) coded for same patient with differing LLTs (Low Level Terms) are counted twice.
|
Other adverse events
Adverse event data not reported
Additional Information
Medical Director, Clinical Science
Takeda Pharmaceuticals Company Limited
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER