A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes

Intarcia Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: glimepiride; Drug: ITCA 650 60 mcg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455883

ITCA 650-CLP-106

Details and patient eligibility

About

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c between 7.5% - 10.5%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion criteria

• on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

ITCA 650 60 mcg/day

Experimental group

Description:

ITCA 650 is exenatide in DUROS

Treatment:

Drug: ITCA 650 60 mcg/day

glimepiride

Active Comparator group

Description:

glimepiride up-titrated to 8 mg/day over first 13 weeks

Treatment:

Drug: glimepiride