Primary outcome
What NCT01003184 measured first
| Exenatide Once Weeklyn=111 | Insulin Detemirn=105 |
|---|---|
| 44.1(34.7 to 53.9) | 11.4(6.0 to 19.1) |
Phase 3 · Exenatide
NCT01003184 trial results
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
Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) (Percentage), Baseline, Week 26. Exenatide Once Weekly: 44.1; Insulin Detemir: 11.4.
- Participants
- 222
- Status
- completed
- Completed
- 2011-12
- Sponsor
- AstraZeneca
As posted on ClinicalTrials.gov (NCT01003184), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT01003184
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide Once Weekly | Insulin Detemir |
|---|---|---|
| Any serious event | 5.4% | 5.7% |
| Nausea | 47.7% | 11.4% |
| Nasopharyngitis | 20.7% | 29.5% |
| Headache | 20.7% | 14.3% |
| Injection site nodule | 19.8% | 0% |
| Diarrhoea | 17.1% | 10.5% |
| Vomiting | 14.4% | 8.6% |
| Injection site pruritus | 10.8% | 1% |
| Constipation | 9% | 2.9% |
| Cough | 6.3% | 8.6% |
| Back pain | 8.1% | 6.7% |
| Oropharyngeal pain | 3.6% | 7.6% |
| Dyspepsia | 6.3% | 1% |
| Musculoskeletal | 6.3% | 1.9% |
| Lower respiratory tract infection | 4.5% | 5.7% |
| Influenza | 1.8% | 5.7% |
| Arthralgia | 4.5% | 5.7% |
| Malaise | 5.4% | 1.9% |
| Pain in extremity | 5.4% | 2.9% |
Secondary outcomes
What else it measured
| Exenatide Once Weeklyn=107 | Insulin Detemirn=101 |
|---|---|
| 58.9(49.0 to 68.3) | 17.8(10.9 to 26.7) |
| Exenatide Once Weeklyn=95 | Insulin Detemirn=96 |
|---|---|
| -1.32(0.076) | -0.91(0.077) |
| Exenatide Once Weeklyn=96 | Insulin Detemirn=98 |
|---|---|
| -2.79(0.347) | 0.88(0.351) |
| Exenatide Once Weeklyn=111 | Insulin Detemirn=105 |
|---|---|
| 66.7(57.1 to 75.3) | 54.3(44.3 to 64.0) |
| Exenatide Once Weeklyn=111 | Insulin Detemirn=105 |
|---|---|
| 51.4(41.7 to 61.0) | 34.3(25.3 to 44.2) |
| Exenatide Once Weeklyn=111 | Insulin Detemirn=105 |
|---|---|
| 27.9(19.8 to 37.2) | 7.6(3.3 to 14.5) |
| Exenatide Once Weeklyn=108 | Insulin Detemirn=104 |
|---|---|
| -2.33(0.191) | -2.43(0.196) |
| Exenatide Once Weeklyn=95 | Insulin Detemirn=98 |
|---|---|
| -7.37(1.342) | -2.65(1.339) |
| Exenatide Once Weeklyn=95 | Insulin Detemirn=98 |
|---|---|
| -0.79(0.855) | -0.34(0.859) |
| Exenatide Once Weeklyn=105 | Insulin Detemirn=100 |
|---|---|
| -0.09(0.067) | 0.06(0.068) |
| Exenatide Once Weeklyn=105 | Insulin Detemirn=100 |
|---|---|
| 0.02(0.014) | 0.04(0.015) |
| Exenatide Once Weeklyn=105 | Insulin Detemirn=100 |
|---|---|
| -0.01(0.079) | -0.08(0.081) |
The trial
How NCT01003184 was run
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.
- 1
- 2
Who could join the trial
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
Published papers
Papers from NCT01003184
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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