Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

NCT02045290 | Completed Phase 3 DMC

• 1 other identifier: T1DX Insulin Clamp Ancillary
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to \<20 year olds with BMI \>85th percentile ( total daily insulin dose \>0.7 units/kg, and HbA1c 7.0%-9.9%).

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in insulin resistance (IR) from baseline to 13 weeks

  Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).

  0-13 weeks

Secondary Outcomes (2)

• Change in Hepatic IR from baseline to 13 weeks

  0-13 weeks

• Change in Adipose IR from baseline to 13 weeks

  0-13 weeks

Study Arms (2)

Oral Placebo

PLACEBO COMPARATOR

A central pharmacy will compound a placebo to match the metformin tablets. The placebo product will contain the following components: * Micosolle™, silica based excipient * Silicified Micro Crystalline Cellulose, National Formulary * Safflower Oil, United States Pharmacopeia * K-30 Povidone Powder * Magnesium Stearate, National Formulary (Vegetable source) * Fumed Silica, National Formulary

Drug: Placebo

Metformin

EXPERIMENTAL

Metformin 2000 mg per day

Drug: Metformin

Interventions

Metformin DRUG

The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in the morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.

Metformin

Placebo DRUG

Oral Placebo

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).

You may not qualify if:

• \. Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit \<30% or hemoglobin \<10 gm/dL

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Related Publications (46)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kellee M Miller, MPH

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Ingrid Libman, MD, PhD

  Childrens Hospital of University of Pittsburgh Medical Center

  STUDY CHAIR

• Kristen Nadeau, MD

  University of Colorado Denver/Childrens Hospital Colorado

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: February 15, 2016
• Study Completion: February 15, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)