Trial Outcomes & Findings for Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes (NCT NCT01223196)

NCT ID: NCT01223196

Last Updated: 2016-01-11

Results Overview

Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment. The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-01-11

Participant Flow

Total of 60 patients were screened and 24 met the eligibility criteria and were randomized.

36 patients did not meet the eligibility criteria and were excluded.

Participant milestones

Measure	Placebo One arm of the study subjects will be treated with Placebo only, once a day.	Pioglitazone One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
Overall Study STARTED	13	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Placebo One arm of the study subjects will be treated with Placebo only, once a day.	Pioglitazone One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
Overall Study Lost to Follow-up	2	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Placebo n=13 Participants One arm of the study subjects will be treated with Placebo only.	Pioglitazone n=11 Participants One arm of the study subjects will be treated with Pioglitazone	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 7 • n=5 Participants	56.6 years STANDARD_DEVIATION 9.3 • n=7 Participants	55.7 years STANDARD_DEVIATION 8.03 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: M/I

Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment.

The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)

Outcome measures

Measure	Placebo n=9 Participants One arm of the study subjects will be treated with Placebo only.	Pioglitazone n=11 Participants One arm of the study subjects will be treated with Pioglitazone
Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp M/I at baseline	3.2 Mg. of glucose/kg body w./mUxl ins. Standard Error 0.01	3.01 Mg. of glucose/kg body w./mUxl ins. Standard Error 0.02
Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp M/I after 6 months of treatment	3.4 Mg. of glucose/kg body w./mUxl ins. Standard Error 0.02	3.7 Mg. of glucose/kg body w./mUxl ins. Standard Error 0.01

SECONDARY outcome

Timeframe: 6 months

Population: These individuals completed both the baseline and all intermediate and the end of study visits.

The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.)

Outcome measures

Measure	Placebo n=9 Participants One arm of the study subjects will be treated with Placebo only.	Pioglitazone n=11 Participants One arm of the study subjects will be treated with Pioglitazone
Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle. TACE Activity at baseline (F.U./mg/prot)	0.2 Tace Activity in F.U./mg prot Standard Error 0.03	0.28 Tace Activity in F.U./mg prot Standard Error 0.04
Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle. TACE Activity after 6 months(F.U./mg/prot)	0.15 Tace Activity in F.U./mg prot Standard Error 0.02	0.06 Tace Activity in F.U./mg prot Standard Error 0.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).

Outcome measures

Measure	Placebo n=9 Participants One arm of the study subjects will be treated with Placebo only.	Pioglitazone n=11 Participants One arm of the study subjects will be treated with Pioglitazone
Percentage (%) of Haemoglobin A1C HbA1c - baseline	8.0 Percentage (%) of HbA1c Standard Error 0.5	7.0 Percentage (%) of HbA1c Standard Error 0.2
Percentage (%) of Haemoglobin A1C HbA1c- after 6 months	7.7 Percentage (%) of HbA1c Standard Error 0.5	6.5 Percentage (%) of HbA1c Standard Error 0.2

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=13 participants at risk One arm of the study subjects will be treated with Placebo only.	Pioglitazone n=11 participants at risk One arm of the study subjects will be treated with Pioglitazone
Blood and lymphatic system disorders anemia	7.7% 1/13 • Number of events 1	0.00% 0/11

Additional Information

Franco Folli, MD PhD/Professor

UT Health Science Center San Antonio

Phone: 210-567-4826

Email: FOLLI@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place