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OpenTrials
Completed

NCT Number: NCT01798264

Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miami Gardens, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes >6 months
  • stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

Exclusion criteria

  • prior treatment with exenatide
  • history of pancreatitis
  • history of medullary thyroid cancer or multiple endocrine neoplasia 2

Treatment and study plan

ITCA 650 (exenatide in DUROS)

Drug

Primary outcomes

  1. Number of Subjects With Study Drug-Related Adverse Events

    Time frame: 4 weeks

Secondary outcomes

  1. To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

    Time frame: 4 weeks

    Change in HbA1c from baseline

  2. Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline

    Time frame: 4 weeks

  3. Change in Weight From Baseline to 4 Weeks

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Intarcia Therapeutics

Industry

Registry information

Official study title

A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2013
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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