Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

• ClinicalTrials.gov Identifier: NCT03060980
• Recruitment Status: Terminated
• First Posted: February 23, 2017
• Last Update Posted: March 7, 2019
• Sponsor: Intarcia Therapeutics
• Information provided by (Responsible Party): Intarcia Therapeutics

Tracking Information

• First Submitted Date: February 9, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: March 7, 2019
• Actual Study Start Date: March 3, 2017
• Actual Primary Completion Date: January 26, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 17, 2017)

• Reduction in glycosylated hemoglobin A1c [ Time Frame: Randomization to 69 weeks ]
  To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
• Reduction in weight [ Time Frame: Randomization to 69 weeks ]
  To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
• Official Title: A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
• Brief Summary: A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: ITCA 650 20/60 mcg/day
  ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
• Drug: Empagliflozin (oral)
  10 mg/day and 25 mg/day
• Drug: Glimepiride (oral)
  1-6 mg/day

Study Arms

• Experimental: Experimental: Group 1
  ITCA 650 20/60 mcg/day
  Intervention: Drug: ITCA 650 20/60 mcg/day
• Experimental: Experimental: Group 2
  Empagliflozin 10 mg/day and 25 mg/day
  Intervention: Drug: Empagliflozin (oral)
• Experimental: Experimental: Group 3
  Glimepiride 1-6 mg/day
  Intervention: Drug: Glimepiride (oral)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: August 6, 2018): 245
• Original Estimated Enrollment (submitted: February 17, 2017): 930
• Actual Study Completion Date: January 26, 2018
• Actual Primary Completion Date: January 26, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of T2D 3 months prior to the Screening Visit.
• Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
• Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

Exclusion Criteria:

• History of type 1 diabetes.
• Prior participation in a clinical study involving ITCA 650.
• Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
• 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 medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
• Treatment of medications that affect GI motility.
• History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
• Women that are pregnant, lactating, or planning to become pregnant.
• Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03060980
• Other Study ID Numbers: ITCA 650-CLP-203
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Intarcia Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Intarcia Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Intarcia Therapeutics
• Verification Date: March 2019