| In this small placebo-controlled single-blind crossover study of subjects with Type 2 DM, exendin-4, vs placebo, was more effective at lowering post-prandial blood glucose levels. In fasting subjects, a dose-dependent rise in insulin concentrations was demonstrated. The short duration of the study (five days), the DOE outcomes (blood glucose levels), and the lack of sufficient power to examine either short or long-term outcomes (either beneficial or hazardous) limits the conclusions that may be drawn regarding use of this agent. We estimated that a 12 day supply to the patient would (at current cost) cost approximately $200.00. Practitioners should await larger, longer and patient-oriented studies before changing their current practice re: diabetes care. |
Citation/s:
Kolterman OG et al. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasm glucose in subjects with type 2 diabetes. Jour Clin Endocrin and Metab 88(7):3082-3089.
Lead author's name and fax: Kolterman OG.
Three-part Clinical Question: In patients with non-controlled but stable Type 2 DM is treatment with exendin-4 more effective than placebo at reducing 2 hour post-prandial plasma glucose?
Search Terms:
The Study:
Single-blinded non-randomised trial with intention-to-treat.
The Study Patients: 18-65 years, stable HBA1C less than 12, over 7.5%. Men, women. Patients were previously treated with diet therapy, any oral antidiabetic agent (OAA) or insulin, plus or minus any OAA.
of note, significant #s Hispanic patients were included
Control group (N = ; analysed): Subcutaneous placebo injection.
Crossover design, order randomized but all patients in effect served as their own controls.
Experimental group (N = ; analysed): Subcutaneous study drug injection; results followed for 300 min total. Glucose results were approximately at baseline by 300 min time
The Evidence:
| Outcome | Time to Outcome | CER | EER | RRR | ARR | NNT |
| 95% Confidence Intervals: | ||||||
| Measure | Control Group | Experimental Group | Difference | 95% CI | ||
|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | |||
| PP plasma glu (mg/dl) 120 min (graph est) | 289 | 144 | ||||
| Non-Event Outcomes | Time to outcome/s | Control group | Experimental group | P-value |
|---|---|---|---|---|
| Adverse events attributed to study medication | not specified | Nausea: 17 events Vomiting 18 events Headache: 27 events |
Comments:
This was a very small drug-company funded study. This study provided no information on the performance of this medication vs. other established drugs. Delayed gastric emptying may increase early satiety, and some patients did lose weight on this medication. Side effects included nausea, headache, and vomiting. Subgroups (degree of control, etc) were too small to speculate on whether specific patient subgroups might benefit more, but seemed to show similar effects. Long-term outcomes cannot be implied, nor can we conclude that the important patient-oriented outcomes of decreased cardiovascular events, or decreased neuropathy, retinopathy and nephropathy will follow from use of this agent.
Appraised by: CAT author: Linda Olson Douglas, MD; JC leader Nate Grunwald, MD; Wednesday, October 19, 2005
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