A Comparison of Exenatide and Insulin Glargine

Type 2 Diabetes Clinical Trial

Official title:

A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in T2DM Patients Inadequately Controlled With Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325960
• Other study ID #: ISSEXEN0034
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2014
• Last updated: February 21, 2017
• Start date: January 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.

Description:

Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (?1500mg/d, ?8 weeks)

3. Male or female age ? 18 years and ?70 years old

4. HbA1c ?7.0 and ?10%

5. BMI ? 24 kg/m2

Exclusion Criteria:

1. Known or suspected allergy to trial products or related products.

2. Impaired renal function defined as serum-creatinine = 1.5 mg/dl (= 133 umol/l).

3. Acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.

4. Abnormal liver function, alanine transaminase or aspartate aminotransferase = 3 fold normal upper limit, Total bilirubin = 2 normal upper limit, acute alcohol intoxication, alcoholism.

5. Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class ? and ?).

6. Proliferative retinopathy or muscular oedema requiring acute treatment.

7. Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).

8. Treatment with systemic corticosteroids within the past two months prior to screening.

9. Type 1 diabetes mellitus.

10. Receipt of any investigational drug within 1 month prior to this trial.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• exenatide
5 µg BID for the first 4 weeks of treatment and 10 µg thereafter.
• Insulin glargine
=8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks.

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with exenatide or insulin glargine adverse events as a measure of safety and tolerability:	hypoglycemia reaction; blood glucose lower than 3.1mmol/L; nausea, vomiting, diarrhea, anorexia or abdominal pain after exenatide subcutaneous injection.	-7±3d;1±3d;7±2d;14±3d;21±2d;28±3d;35±3d;56±3d;84±3d;112±3d
Other	Exploratory Objective assessed by the relationships between oxidative stress and inflammatory markers and MAGE	Whether there is linear correlation between oxidative stress markers and MAGE, and between inflammatory markers and MAGE, and correlation coefficient of each correlation	1±3d;112±3d
Primary	Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)		1±3day;112±3d
Secondary	Glycemic variability	continuous overlapping net glycemic action (CONGA) and mean of daily differences (MODD)	1±3day;112±3d
Secondary	Glucose control	Glycosylated hemoglobin A 1c (HbA1c), FBG, postprandial blood glucose (PBG)	-7±3d;112±3d;
Secondary	oxidative stress markers	plasma concentrations of superoxide dismutase (SOD), malondialdehyde, 8-iso-prostaglandin-F2a (8-iso-PGF2a) and urine concentrations of 8-iso-PGF2a;	1±3d;28±3d;56±3d;84±3d;112±3d
Secondary	inflammatory markers	plasma concentrations of interleukin-1(IL-1), interleukin-18(IL-18), adiponectin, toll-like receptor 4(TLR-4) and phosphorylated-nuclear factor-kappaB 65 (pNF-?B 65) in white blood cells	1±3d;28±3d;56±3d;84±3d;112±3d
Secondary	endothelial function	plasma total nitric oxide synthase (tNOS), inducible nitric oxide synthase (iNOS), nitric oxide (NO)	1±3d;28±3d;56±3d;84±3d;112±3d
Secondary	beta-cell function and insulin resistance	homeostasis model assessment-ß, homeostasis model assessment -insulin resistance, plasma glucagon, body mass index (BMI), waist-hip ratio	1±3d;112±3d;
Secondary	body composition	fat mass, lean tissue, body weight, waist circumference	1±3d;112±3d