A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

NCT00516074 | Completed Phase 3 Results

• 1 other identifier: H8O-MC-GWCD
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 6

Brief Summary

This study will explore the effect of exenatide (given twice a day) versus placebo (given twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug exposure in patients with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatide; Byetta; type 2 diabetes; heart rate; Amylin; Lilly

Outcome Measures

Primary Outcomes (1)

• Change in Mean 24-hour Heart Rate From Baseline to Endpoint

  Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.

  12 weeks

Secondary Outcomes (5)

• Change in Daytime Heart Rate From Baseline to Endpoint

  12 weeks

• Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint

  12 weeks

• Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint

  12 weeks

• Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint

  12 weeks

• Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

  12 weeks

Study Arms (2)

Exenatide Arm

EXPERIMENTAL

This arm will receive 5mcg exenatide for 4 weeks, and then 10mcg exenatide for the remaining 8 weeks of the study.

Drug: exenatide

Placebo Arm

PLACEBO COMPARATOR

This arm will receive placebo injection (volume equivalent to the exenatide injection in the experimental arm).

Drug: placebo

Interventions

exenatide DRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

Also known as: Byetta, AC2993, LY2148568

Exenatide Arm

placebo DRUG

subcutaneous injection, volume equivalent to active, twice a day

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes.
• Treated with metformin and/or a thiazolidinedione.
• HbA1c between 6.5% and 9.5%, inclusive.
• Body Mass Index (BMI) \> 25 kg/m\^2 and \< 40 kg/m\^2.

You may not qualify if:

• Have previously received exenatide or glucagon-like peptide-1 analogs.
• Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
• Receiving beta blockers.
• Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
• Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.
• Have been treated with drugs that promote weight loss (for example, Adipex® \[phentermine\], Acomplia® \[rimonabant\], Xenical® \[orlistat\], Meridia® \[sibutramine\], Acutrim® \[phenylpropanolamine\], or similar over-the-counter medications) within 3 months of screening.
• Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: \*Insulin; \*Alpha-glucosidase inhibitors (for example, Glyset® \[miglitol\] or Precose® \[acarbose\]); \*Meglitinides (for example, Prandin® \[repaglinide\] or Starlix® \[nateglinide\]); \*Sulfonylureas (for example, Glucotrol® \[glipizide\] or Micronase® \[glyburide\]); \*Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ \[sitagliptin\])
• Have donated blood within 60 days of screening.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (6)

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Etten-Leur, Netherlands

Location

Research Site

Leiden, Netherlands

Location

Research Site

Rotterdam, Netherlands

Location

Research Site

Utrecht, Netherlands

Location

Related Publications (1)

• Gill A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J. Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol. 2010 Jan 28;9:6. doi: 10.1186/1475-2840-9-6.

  PMID: 20109208 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

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

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Chief Medical Officer, MD

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 14, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 7, 2015
• Results First Posted: June 12, 2009

Record last verified: 2015-03

Locations

NL (4); CA (2)