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Completed

NCT Number: NCT01003184

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Dublin, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

exenatide once weekly

Drug

subcutaneous injection, 2mg, once a week

insulin detemir

Drug

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

Other names: Levemir

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, Week 26

    Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)

  2. Change in HbA1c From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in HbA1c from baseline to week 26

  3. Change in Body Weight From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in body weight from baseline to week 26

  4. Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

    Time frame: Week 26

    Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint

  5. Percentage of Patients Achieving ≤7.0% at Endpoint

    Time frame: Week 26

    Percentage of patients achieving ≤7.0% at endpoint.

  6. Percentage of Patients Achieving ≤6.5% at Endpoint

    Time frame: Week 26

    Percentage of patients achieving HbA1c ≤6.5% at endpoint

  7. Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).

    Time frame: Baseline, Week 26

    Change in fasting serum glucose from baseline to endpoint (Week 26).

  8. Changes in Systolic Blood Pressure From Baseline to Week 26

    Time frame: Baseline, Week 26

    Change in systolic blood pressure from baseline to Week 26

  9. Change in Diastolic Blood Pressure From Baseline to Week 26.

    Time frame: Baseline, Week 26

    Change in diastolic blood pressure from baseline to week 26.

  10. Change in Total Cholesterol From Baseline to Endpoint (Week 26).

    Time frame: Baseline, Week 26

    Change in total cholesterol from baseline to endpoint (week 26).

  11. Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).

    Time frame: Baseline, Week 26

    Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).

  12. Change in Triglycerides From Baseline to Endpoint (Week 26).

    Time frame: Baseline, Week 26

    Change in triglycerides from baseline to endpoint (week 26).

  13. Hypoglycemia Rate Per Year

    Time frame: Baseline, Week 26

    All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2009
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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