Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 23, 2015
Last Update Posted Date November 5, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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
  • Incidence of hypoglycemia [ Time Frame: From Randomization to 34 weeks ]
  • Change in percentage of glycosylated hemoglobin (HbA1c) in the blood [ Time Frame: From baseline to Week 26 ]
  • Change in body weight [ Time Frame: from baseline to Week 26 ]
    Change from baseline in body weight at Week 26
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2015)
  • 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
  • Change from baseline in fasting plasma glucose [ Time Frame: from baseline to Week 26 ]
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
    ITCA 650 osmotic mini pump delivering exenatide 20/60 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)
Study Arms  ICMJE
  • Experimental: Group 1
    ITCA 650 20/60 mcg/day
    Interventions:
    • Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
    • Drug: Metformin
    • Drug: Liraglutide
  • Experimental: Group 2
    ITCA 650 60 mcg/day
    Interventions:
    • Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day
    • Drug: Metformin
    • Drug: Liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2017)
136
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2015)
126
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02638805
Other Study ID Numbers  ICMJE ITCA 650-CLP-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intarcia Therapeutics
Study Sponsor  ICMJE Intarcia Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Intarcia Therapeutics
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP