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Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

I

Intarcia Therapeutics

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Metformin
Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day
Drug: Liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02638805
ITCA 650-CLP-201

Details and patient eligibility

About

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

Enrollment

136 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of type 2 diabetes ≥ 3 months.
  • Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
  • HbA1c ≤9.5%.
  • Stable body weight ≥ 3 months.
  • Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
  • Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.

Exclusion criteria

  • History of type 1 diabetes.
  • Recent use or of anti-diabetic medications other than liraglutide or metformin.
  • History of significant/severe nausea and/or vomiting due to liraglutide.
  • Significant symptomatic hyperglycemia.
  • History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
  • History or evidence of acute or chronic pancreatitis.
  • History of liver disease.
  • History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
  • Poor thyroid, liver, or renal function.
  • Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123 μmol/L) for female patients.
  • Weight loss surgery or requires weight loss medications.
  • History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
  • History of active alcohol or substance abuse.
  • Treatment with medications that affect GI motility.
  • History of hypersensitivity to exenatide or liraglutide.
  • Women that are pregnant, lactating, or planning to become pregnant.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

Group 1
Experimental group
Description:
ITCA 650 20/60 mcg/day
Treatment:
Drug: Liraglutide
Drug: Metformin
Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
Group 2
Experimental group
Description:
ITCA 650 60 mcg/day
Treatment:
Drug: Liraglutide
Drug: Metformin
Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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