Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Jaeb Center for Health Research

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02045290

T1DX Insulin Clamp Ancillary

Details and patient eligibility

About

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%).

Enrollment: 37 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

37 participants in 2 patient groups, including a placebo group

Oral Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Metformin

Experimental group

Description:

Metformin 2000 mg per day

Treatment:

Drug: Metformin