Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: AC2993; Drug: Placebo

• Registration Number: NCT00039026
• Lead Sponsor: AstraZeneca

Brief Summary

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (sulfonylurea) throughout the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-06-06
• Study First Submitted QC: 2002-06-07
• Study First Posted: 2002-06-10
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• Subjects with Type 2 diabetes mellitus
• Treated with a sulfonylurea at defined doses for at least 3 months prior to screening
• BMI= 27-45 kg/m2
• HbA1c value between 7.5% and 11%

Exclusion Criteria

• Treated with oral anti-diabetic medications other than a sulfonylurea within 3 months of screening
• Patients treated previously with AC2993
• Patients presently treated with insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC2993 5 mcg (0.02 mL)	AC2993	Placebo, then AC2993 5 mcg, then AC2993 5 mcg
Placebo 0.02 mL	Placebo	Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
AC2993 10mcg (0.04 mL)	AC2993	Placebo, then AC2993 5 mcg, then AC2993 10 mcg
Placebo 0.04 mL	Placebo	Placebo 0.02 mL / Placebo 0.02 mL / Placebo 0.04 mL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from Baseline to Week 30	Baseline (Day 1) to Week 30	Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

Secondary Outcome Measures

Name	Time	Method
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30	Baseline (Day 1), and Week 30	The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30)
Change in HbA1c from baseline (Day 1) to each of the intermediate visits	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24	Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30	The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more
Change in body weight from Baseline to each intermediate visit and Week 30	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30	Change in body weight (kg) from Baseline to each intermediate visit and Week 30
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30	Baseline (Day 1) and Week 30	The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30)
The time to achieve specific HbA1c target values of < 7% and < 8%	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30	The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8%

Trial Locations

Locations (123)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Parkway Medical Center; 🇺🇸 Birmingham, Alabama, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Eclectic Family Care; 🇺🇸 Eclectic, Alabama, United States

Winston Physician Services; 🇺🇸 Haleyville, Alabama, United States

Simon Williamson Clinic; 🇺🇸 Hueytown, Alabama, United States

Extended Arm Physicians/ Southern Drug; 🇺🇸 Montgomery, Alabama, United States

Southern Drug Research Network; 🇺🇸 Tallassee, Alabama, United States

Clinic of Physicians and Surgeons, Ltd.; 🇺🇸 Mesa, Arizona, United States

ANA Ventures, LLC; 🇺🇸 Mesa, Arizona, United States

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