Trial Outcomes & Findings for Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease (NCT NCT01006889)

NCT ID: NCT01006889

Last Updated: 2016-09-28

Results Overview

Hepatic steatosis was assessed non-invasively by MRS.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2016-09-28

Participant Flow

24 subjects recruited at the ALMVA hospital and University Hospital starting in 2006

24 participants signed informed consent, however only 20 started the study.

Participant milestones

Measure	Exenatide (Twice Daily) The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

Exenatide (Twice Daily) The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Overall Study Withdrawal by Subject

3

Baseline Characteristics

Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease

Baseline characteristics by cohort

Measure	Exenatide (Twice Daily) n=20 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Hepatic steatosis was assessed non-invasively by MRS.

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Hepatic Steatosis

4.0 Percentage of liver fat Standard Deviation 2.6

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population.

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

A1c

6.8 percentage of A1c Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Change in Anthropometric Variables (Weight).

-4.7 Kg Standard Deviation 18.4

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.

0 number of events

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Change in C-peptide levels vs. pretreatment in the first and second phase.

Outcome measures

Measure	Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
Insulin Secretion (Hyperglycemic Clamp) Delta first phase insulin secretion	-0.1 ng/ml Standard Deviation 1.6
Insulin Secretion (Hyperglycemic Clamp) Delta second phase insulin secretion	1.1 ng/ml Standard Deviation 2.8

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

M value represents glucose infusion change

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp

30 percentage change vs pretreatment Standard Deviation 14

SECONDARY outcome

Timeframe: 6 months

Population: Number of patients completing.

Change in lipid levels vs. pretreatment.

Outcome measures

Measure	Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience). Cholesterol	-4 mg/dl Standard Deviation 29
Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience). Triglyceride	21 mg/dl Standard Deviation 54
Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience). LDL-C	-8 mg/dl Standard Deviation 26
Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience). HDL-C	-1 mg/dl Standard Deviation 6

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants included were the ones that completed the study.

Outcome measures

Measure

Exenatide (Twice Daily) n=17 Participants The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

Change in Anthropometric Variables (BMI).

-1.5 Kg/m2 Standard Deviation 4.7

Adverse Events

Exenatide (Twice Daily)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Exenatide (Twice Daily) n=20 participants at risk The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.

General disorders nausea

15.0% 3/20 • Number of events 3

Additional Information

Dr. Kenneth Cusi

University of Florida

Phone: 352-273-8661

Email: kcusi@ufl.edu

Results disclosure agreements

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