Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

NCT01003184 | Completed Phase 3 Results

• 1 other identifier: H8O-EW-GWDL
• Study Type: interventional
• Target: 222
• Locations: 2 countries
• Sites: 34

Brief Summary

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; exenatide once weekly; Byetta; insulin detemir; Levemir; Amylin; Lilly

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

  The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c \<=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.

  Baseline, Week 26

Secondary Outcomes (13)

• Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)

  Baseline, Week 26

• Change in HbA1c From Baseline to Week 26

  Baseline, Week 26

• Change in Body Weight From Baseline to Week 26

  Baseline, Week 26

• Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

  Week 26

• Percentage of Patients Achieving ≤7.0% at Endpoint

  Week 26

Study Arms (2)

1

EXPERIMENTAL

Drug: exenatide once weekly

2

ACTIVE COMPARATOR

Drug: insulin detemir

Interventions

exenatide once weekly DRUG

subcutaneous injection, 2mg, once a week

1

insulin detemir DRUG

subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day

Also known as: Levemir

2

Eligibility Criteria

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

You may qualify if:

• Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
• Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
• Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

You may not qualify if:

• Have any contraindication for the OAD that they have been using
• Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
• Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
• Have been treated with drugs that promote weight loss, 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, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
• Have previously completed or withdrawn from this study or any other study investigating exenatide QW
• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (34)

Research Site

Dublin, Ireland

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Addlestone, England, United Kingdom

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Bath, England, United Kingdom

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Birmingham, England, United Kingdom

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Blackburn, England, United Kingdom

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Bournemouth, England, United Kingdom

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Chippenham, England, United Kingdom

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Derby, England, United Kingdom

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Exeter, England, United Kingdom

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High Wycombe, England, United Kingdom

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Hull, England, United Kingdom

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Leicester, England, United Kingdom

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Liverpool, England, United Kingdom

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London, England, United Kingdom

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Manchester, England, United Kingdom

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Merseyside, England, United Kingdom

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Middlesbrough, England, United Kingdom

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Newcastle, England, United Kingdom

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Northampton, England, United Kingdom

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Oldham, England, United Kingdom

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Plymouth, England, United Kingdom

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Portsmouth, England, United Kingdom

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Sheffield, England, United Kingdom

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Stevenage, England, United Kingdom

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Suffolk, England, United Kingdom

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Wakefield, England, United Kingdom

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Wiltshire, England, United Kingdom

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Aberdeen, Scotland, United Kingdom

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Dundee, Scotland, United Kingdom

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Carmathen, Wales, United Kingdom

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Swansea, Wales, United Kingdom

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Wrexham, Wales, United Kingdom

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Leytonstone, United Kingdom

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Livingston, United Kingdom

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Related Publications (1)

• Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.

  PMID: 32306296 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 28, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 7, 2015
• Results First Posted: December 18, 2012

Record last verified: 2015-03

Locations

GB (33); IE (1)