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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638805
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day Drug: Metformin Drug: Liraglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
Study Start Date : December 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
ITCA 650 20/60 mcg/day
Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day

Drug: Metformin
Stable dose for at least 3 months (at least 1000 mg/day)

Drug: Liraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)

Experimental: Group 2
ITCA 650 60 mcg/day
Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day

Drug: Metformin
Stable dose for at least 3 months (at least 1000 mg/day)

Drug: Liraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)




Primary Outcome Measures :
  1. Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting [ Time Frame: From Randomization to 34 weeks ]
    Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.


Secondary Outcome Measures :
  1. Number (percentage) and severity of all treatment-emergent adverse events [ Time Frame: From Randomization to 34 weeks ]
    All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide

  2. Incidence of hypoglycemia [ Time Frame: From Randomization to 34 weeks ]
  3. Change in percentage of glycosylated hemoglobin (HbA1c) in the blood [ Time Frame: From baseline to Week 26 ]
  4. Change in body weight [ Time Frame: from baseline to Week 26 ]
    Change from baseline in body weight at Week 26


Other Outcome Measures:
  1. Change from baseline in blood pressure and heart rate [ Time Frame: from baseline to 34 weeks ]
    Change from baseline in blood pressure and heart rate at Week 26

  2. Change from baseline in fasting plasma glucose [ Time Frame: from baseline to Week 26 ]
  3. Change from baseline in cholesterol [ Time Frame: from baseline to Week 26 ]
    Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638805


Locations
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Sponsors and Collaborators
Intarcia Therapeutics
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Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT02638805    
Other Study ID Numbers: ITCA 650-CLP-201
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Liraglutide
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Obesity Agents