A Comparison of Exenatide and Insulin Glargine

NCT02325960 | Completed Phase 4 DMC

• 1 other identifier: ISSEXEN0034
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

exenatide; insulin glargine

Outcome Measures

Primary Outcomes (1)

• Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)

  1±3day；112±3d

Secondary Outcomes (7)

• Glycemic variability

  1±3day；112±3d

• Glucose control

  -7±3d；112±3d；

• oxidative stress markers

  1±3d；28±3d；56±3d；84±3d；112±3d

• inflammatory markers

  1±3d；28±3d；56±3d；84±3d；112±3d

• endothelial function

  1±3d；28±3d；56±3d；84±3d；112±3d

Other Outcomes (2)

• Number of Participants with exenatide or insulin glargine adverse events as a measure of safety and tolerability:

  -7±3d；1±3d；7±2d；14±3d；21±2d；28±3d；35±3d；56±3d；84±3d；112±3d

• Exploratory Objective assessed by the relationships between oxidative stress and inflammatory markers and MAGE

  1±3d；112±3d

Study Arms (2)

exenatide

ACTIVE COMPARATOR

5 μg BID for the first 4 weeks of treatment and 10 μg thereafter

Drug: exenatide; Drug: Insulin glargine

Insulin glargine

ACTIVE COMPARATOR

≥8 IU QD, and titrate based on a dosing algorithm targeting FPG \<6.1 mmol/L. Titration is only allowed in first 4 weeks.

Drug: exenatide; Drug: Insulin glargine

Interventions

exenatide DRUG

5 μg BID for the first 4 weeks of treatment and 10 μg thereafter.

Also known as: Byetta.Lilly

Insulin glargine; exenatide

Insulin glargine DRUG

≥8 IU QD, and titrate based on a dosing algorithm targeting FPG \<6.1 mmol/L. Titration is only allowed in first 4 weeks.

Also known as: Lantus,Sanofi Aventis

Insulin glargine; exenatide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
• Male or female age ≧ 18 years and ≦70 years old
• HbA1c ≧7.0 and ≦10%
• BMI ≧ 24 kg/m2

You may not qualify if:

• Known or suspected allergy to trial products or related products.
• Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
• Acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
• Abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, Total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
• 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 Ⅲ and Ⅳ).
• Proliferative retinopathy or muscular oedema requiring acute treatment.
• 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).
• Treatment with systemic corticosteroids within the past two months prior to screening.
• Type 1 diabetes mellitus.
• Receipt of any investigational drug within 1 month prior to this trial.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Yin TT, Bi Y, Li P, Shen SM, Wang WM, Jiang C, Gao CX, Wang Y, Gao LJ, Zhu DL, Feng WH. Effects of exenatide versus insulin glargine on body composition in overweight and obese T2DM patients: a randomized controlled trial. Nutr Metab (Lond). 2018 Oct 1;15:67. doi: 10.1186/s12986-018-0295-6. eCollection 2018.

  PMID: 30302121 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dalong Zhu, MD PhD

  the Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: December 25, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CN (1)