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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01003184 (opens ClinicalTrials.gov in a new tab)Other idH8O-EW-GWDL
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
222 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

Ireland, United Kingdom

Start
Oct 2009
Primary completion
Jul 2011
Completion
Dec 2011
First posted
28 Oct 2009 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

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

    NCT01003184

    Oct 2009 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatide once weeklyDrug
  • insulin detemirDrug

Arms2

  • Experimental

    1

  • Active comparator

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    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(13)

  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

    Registry description

    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

    Registry description

    Change in HbA1c from baseline to week 26

  3. Change in Body Weight From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in body weight from baseline to week 26

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

    Time frame · Week 26

    Registry description

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

  5. Percentage of Patients Achieving ≤7.0% at Endpoint

    Time frame · Week 26

    Registry description

    Percentage of patients achieving ≤7.0% at endpoint.

  6. Percentage of Patients Achieving ≤6.5% at Endpoint

    Time frame · Week 26

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

  13. Hypoglycemia Rate Per Year

    Time frame · Baseline, Week 26

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline, Week 26

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

GroupValue (Percentage)
Exenatide Once Weekly44.1
Insulin Detemir11.4
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline, Week 26

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

GroupValue (Percentage)
Exenatide Once Weekly58.9
Insulin Detemir17.8
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in HbA1c From Baseline to Week 26

GroupValue (Percentage of total hemoglobin)Spread
Exenatide Once Weekly-1.320.076
Insulin Detemir-0.910.077
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in Body Weight From Baseline to Week 26

GroupValue (kilograms)Spread
Exenatide Once Weekly-2.790.347
Insulin Detemir0.880.351
Secondary outcomeNumber· Week 26

Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint

GroupValue (Percentage)
Exenatide Once Weekly66.7
Insulin Detemir54.3
Secondary outcomeNumber· Week 26

Percentage of Patients Achieving ≤7.0% at Endpoint

GroupValue (Percentage)
Exenatide Once Weekly51.4
Insulin Detemir34.3
Secondary outcomeNumber· Week 26

Percentage of Patients Achieving ≤6.5% at Endpoint

GroupValue (Percentage)
Exenatide Once Weekly27.9
Insulin Detemir7.6
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (mmol/L)Spread
Exenatide Once Weekly-2.330.191
Insulin Detemir-2.430.196

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Once WeeklyExenatide once weekly : subcutaneous injection, 2mg, once a week–6 / 11187 / 111
Insulin DetemirInsulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day–6 / 10558 / 105

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2020

Corrected

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.

Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6

PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296

Free to read · publisher termsCC BY-NC
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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