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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01003184
First received: October 15, 2009
Last updated: June 6, 2014
Last verified: June 2014

October 15, 2009
June 6, 2014
October 2009
July 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
To test the hypothesis that exenatide given once weekly is superior to a titration of insulin detemir given once or twice daily assessed by the proportion of patients who have achieved HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003184 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)
  • Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline to week 26
  • Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in body weight from baseline to week 26
  • Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint
  • Percentage of Patients Achieving ≤7.0% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients achieving ≤7.0% at endpoint.
  • Percentage of Patients Achieving ≤6.5% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    Percentage of patients achieving HbA1c ≤6.5% at endpoint
  • Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in fasting serum glucose from baseline to endpoint (Week 26).
  • Changes in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in systolic blood pressure from baseline to Week 26
  • Change in Diastolic Blood Pressure From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure from baseline to week 26.
  • Change in Total Cholesterol From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in total cholesterol from baseline to endpoint (week 26).
  • Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).
  • Change in Triglycerides From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Change in triglycerides from baseline to endpoint (week 26).
  • Hypoglycemia Rate Per Year [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: Yes ]
    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.
  • To compare exenatide QW to insulin detemir with respect to the proportion of patients who have achieved HbA1c ≤7.0% with weight loss (≥1.0 kg) at 12 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to the proportion of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to the proportion of patients who have achieved HbA1c ≤7.0% and ≤7.4%, with minimal weight gain (≤1 kg) at endpoint [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to HbA1c change from baseline [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to change in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to the proportion of patients achieving HbA1c ≤7.4%, ≤7.0% and ≤6.5% at endpoint [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to change in fasting serum glucose [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to 7-point self-monitored blood glucose (SMBG) profile (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir w/respect to changes in CV risk parameters: BMI, waist circumference, systolic/diastolic BP, lipid profile, plasminogen activator inhibitor, high sensitivity C-reactive protein concentrations, adiponectin levels [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir with respect to incidence and rate of hypoglycemic events [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • To compare exenatide QW to insulin detemir over 26 weeks with respect to safety and tolerability [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide once weekly
    subcutaneous injection, 2mg, once a week
  • Drug: insulin detemir
    subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
    Other Name: Levemir
  • Experimental: 1
    Intervention: Drug: exenatide once weekly
  • Active Comparator: 2
    Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
December 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Ireland
 
NCT01003184
H8O-EW-GWDL
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP