Extension Study for 2993-112

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AC2993

• Registration Number: NCT01789957
• Lead Sponsor: AstraZeneca

Brief Summary

This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label AC2993	AC2993	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination)	Day 1 of study 2993-112 through extension study termination (up to Week 52)	Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination)	Day 1 of study 2993-112 through extension study termination (up to Week 52)	Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.

Trial Locations

Locations (212)

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

Mesa Center for Clinical Research; 🇺🇸 Chandler, Arizona, United States

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

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