exenatide and Headache

We explored the safety and efficacy of exenatide BID v. insulin glargine in a subgroup of Polish patients with type 2 diabetes sub-optimally controlled with metformin plus a sulfonylurea, participating in a 26-week randomised, controlled open-label trial.. In Poland, 80 patients (HbA1c 7-10%, BMI 25-45 kg/m(2)) were randomised to exenatide 10 μg BID (n = 40) or insulin glargine once daily (n = 40). We present exploratory analyses on HbA1c, glucose profiles, body weight, hypoglycaemia and adverse events (AEs).. Mean (SD) baseline HbA1c was 7.9% (0.86) for exenatide and 7.8% (1.02) for insulin glargine. At Week 26, LS mean (SEM) HbA1c decreased in both groups (exenatide -0.72% [0.12]; glargine -0.64% [0.12]), as did fasting glucose. Postprandial glucose excursions after breakfast and dinner were smaller in patients treated with exenatide. LS mean (SEM) body weight decreased by -1.9 (0.48) kg with exenatide and increased by 1.6 (0.48) kg with glargine (group difference [95%CI]: -3.5 kg [-4.9 to -2.2]). Hypoglycaemia was low in both groups; nocturnal hypoglycaemia was reported for three v. seven patients (three v. 24 episodes) in the exenatide and glargine groups, respectively. Adverse events were more common with exenatide (nausea n = 22 v. n = 1, vomiting n = 5 v. n = 0, headache n = 8 v. n = 2).. This exploratory analysis confirms that findings from the global study apply to patients treated with exenatide BID and glargine in Poland, showing that exenatide BID was as effective as insulin glargine. Data suggested that changes in HbA1c were similar, with fasting glucose changes greater in the glargine group and postprandial changes greater in the exenatide BID group. Exenatide BID was associated with weight reduction, less nocturnal hypoglycaemia, but more gastrointestinal events compared to glargine.

Topics: Administration, Oral; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Exenatide; Female; Glycated Hemoglobin; Headache; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin Glargine; Insulin, Long-Acting; Male; Metformin; Middle Aged; Nausea; Peptides; Sulfonylurea Compounds; Venoms; Vomiting

Exenatide, a treatment for type 2 diabetes, slows gastric emptying as part of its pharmacologic action and may alter the absorption of concomitant oral drugs. This open-label, 2-period, fixed-sequence study evaluated the influence of exenatide coadministration on the pharmacokinetics and pharmacodynamics of warfarin, a narrow therapeutic index drug, in healthy men (N = 16). A single, 25-mg oral dose of warfarin, with a standardized breakfast, was administered alone in period 1 and concomitantly with 10 microg exenatide subcutaneous twice daily in period 2. Exenatide did not produce significant changes in R- or S-warfarin pharmacokinetics. Although there were minor reductions in warfarin anticoagulant effect, the ratios of geometric means for the area under the international normalized ratio (INR)-time curve from dosing until the time of the last measurable INR value or maximum-observed INR response being 0.94 (0.93-0.96) and 0.88 (0.84-0.92), respectively, the magnitude and direction of these changes do not suggest a safety concern from this interaction.

Topics: Administration, Oral; Adult; Anticoagulants; Area Under Curve; Aryl Hydrocarbon Hydroxylases; Asian People; Chromatography, Liquid; Cytochrome P-450 CYP2C9; Dose-Response Relationship, Drug; Drug Interactions; Exenatide; Genotype; Haplotypes; Headache; Humans; Hypoglycemic Agents; Injections, Subcutaneous; International Normalized Ratio; Male; Mass Spectrometry; Middle Aged; Nausea; Peptides; Venoms; Warfarin