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

I

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Withdrawn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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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