Trial Outcomes & Findings for Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes (NCT NCT01432405)

Results Overview

The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

one year

Results posted on

2016-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Pioglitazone and Exenatide Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.	Pioglitazone Pioglitazone 45 mg daily orally for 12 months Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
Overall Study STARTED	12	12
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pioglitazone and Exenatide n=11 Participants Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.	Pioglitazone n=10 Participants Pioglitazone 45 mg daily orally for 12 months Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.	Total n=21 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	11 Participants n=5 Participants	10 Participants n=7 Participants	21 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	49 years STANDARD_DEVIATION 3 • n=5 Participants	55 years STANDARD_DEVIATION 3 • n=7 Participants	52 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.

Outcome measures

Outcome measures
Measure	Pioglitazone and Exenatide n=11 Participants Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.	Pioglitazone n=10 Participants Pioglitazone 45 mg daily orally for 12 months Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
Hepatic Fat	4.7 percent of liver fat Standard Error 1.3	6.5 percent of liver fat Standard Error 1.9

SECONDARY outcome

Timeframe: one year

the effect of the intervention on plasma adiponectin levels.

Outcome measures

Outcome measures
Measure	Pioglitazone and Exenatide n=11 Participants Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.	Pioglitazone n=10 Participants Pioglitazone 45 mg daily orally for 12 months Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
Plasma Adipocytokines	23.2 microgram per ml Standard Error 2.7	15.8 microgram per ml Standard Error 1.4

Adverse Events

Pioglitazone and Exenatide

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Mandeep Bajaj

Baylor College of Medicine

Phone: 713-798-1712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place