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

I

Intarcia Therapeutics

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: ITCA 650
Other: ITCA placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01455857
ITCA 650-CLP-103

Details and patient eligibility

About

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Enrollment

460 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HbA1c between 7.5% - 10%
  • On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
  • BMI between 25 & 45 kg/m2

Exclusion criteria

  • taking DPP-4 inhibitors, exenatide, liraglutide, 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

460 participants in 3 patient groups, including a placebo group

ITCA 650 40 mcg/day
Experimental group
Treatment:
Drug: ITCA 650
ITCA 650 60 mcg/day
Experimental group
Treatment:
Drug: ITCA 650
ITCA placebo
Placebo Comparator group
Treatment:
Other: ITCA placebo

Trial contacts and locations

122

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Data sourced from clinicaltrials.gov

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