Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01514149
Status:
TERMINATED
Last Update Posted:
2017-07-19
First Post:
2011-10-20
Brief Title:
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
Sponsor:
ConjuChem
Organization:
ConjuChem
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multiple-Dose Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy
Detailed Description:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus T2DM on metformin monotherapy This study will be a randomized double-blind comparison of CJC-1134-PC versus placebo Patients taking metformin will continue to take their metformin at the same dose for the duration of the study
Patients with T2DM who meet all the inclusion criteria and none of the exclusion criteria will be randomly assigned to a treatment arm All patients will undergo weekly clinic visits to receive 17 weeks of study treatment including the titration period
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state Patients will be closely monitored and evaluated for toxicity on an ongoing basis
Patients with T2DM who meet all the inclusion criteria and none of the exclusion criteria will be randomly assigned to a treatment arm All patients will undergo weekly clinic visits to receive 17 weeks of study treatment including the titration period
CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state Patients will be closely monitored and evaluated for toxicity on an ongoing basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None