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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: ITCA 650 20/60 mcg/day Drug: Empagliflozin (oral) Drug: Glimepiride (oral) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Group 1
ITCA 650 20/60 mcg/day
 Drug: ITCA 650 20/60 mcg/day
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Experimental: Experimental: Group 2
Empagliflozin 10 mg/day and 25 mg/day
 Drug: Empagliflozin (oral)
10 mg/day and 25 mg/day
Experimental: Experimental: Group 3
Glimepiride 1-6 mg/day
 Drug: Glimepiride (oral)
1-6 mg/day


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT03060980


Locations
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Sponsors and Collaborators
Intarcia Therapeutics
More Information
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Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT03060980    
Other Study ID Numbers: ITCA 650-CLP-203
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Glimepiride
Exenatide
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Glucagon-Like Peptide-1 Receptor Agonists
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists