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

NCT03060980 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2018-01-26
Completion
2018-01-26
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060980 on ClinicalTrials.gov