Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

AstraZeneca494 enrolled

Overview

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

494

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatide twice daily (BID)DRUG

subcutaneous injection (5 mcg or 10 mcg), twice a day

premixed insulin aspart twice daily (BID)DRUG

subcutaneous injection (titrated appropriately), twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * Have an HbA1c between 6.5% and 10.0%, inclusive * Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive Exclusion Criteria: * Have type 1 diabetes or known latent autoimmune diabetes in adults * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * Have used any prescription drug to promote weight loss within 3 months prior to study start * Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

Locations (39)

Outcomes

Primary Outcomes

Change in Glycosylated Hemoglobin (HbA1c)

Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)

Time frame: Baseline and 26 weeks

Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)

Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26

Time frame: 26 weeks

Secondary Outcomes

Percentage of Subjects Achieving HbA1c Target of < 6.5%

Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\].

Time frame: 26 weeks

Percentage of Subjects Achieving HbA1c Target of < 7.0%

Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\].

Time frame: 26 weeks

Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)

Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\]

Time frame: 26 weeks

Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.