- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01334125
Adjunctive Metformin Therapy in Double Diabetes (AMTIDD)
March 3, 2016 updated by: Benjamin U. Nwosu, University of Massachusetts, Worcester
Glycemic Control in Children and Adolescents With Double Diabetes: Trial of Optimized Insulin-Metformin Regimen
The significance of this project is to investigate the effects of adjunctive metformin therapy in children and adolescents with double diabetes.
Double diabetes describes a clinical state where an individual possesses features of both type 1 and type 2 diabetes.
There is a paucity of data on the role of adjunctive metformin therapy in children and adolescents with double diabetes.
To help fill this knowledge gap, the investigators propose a randomized, double-blind, placebo-controlled trial of metformin in double diabetes.
Specifically, the investigators will evaluate changes in hemoglobin A1c and anthropometry in patients with a diagnosis of type 1 diabetes who also have features of type 2 diabetes or metabolic syndrome as well as patients with type 2 diabetes who possess diabetes-associated autoantibodies.
This will help determine the safety profile, and efficacy of adjunctive metformin therapy in these subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this 12-month clinical trial, a 3-month run-in period will precede the interventional phase of the study.
All patients will be placed on treat-to-target insulin regimen alone during the run-in phase.
At the end of the 3-month run-in period, all participants will continue on treat-to-target insulin regimen, and will then be randomized to either of the 2 arms of the study: an experimental arm, consisting of treat-to-target insulin regimen plus metformin, and a control arm consisting of treat-to-target insulin regimen plus placebo.
Both the physicians and patients will be blinded to the oral agents being administered to patients.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Worcester, Massachusetts, United States, 01655
- UmassMemorial Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
A. General inclusion criteria
- Ten to 20 years of age.
- Pubertal (Tanner stages 2-5, by examination).
- Hemoglobin A1c level of > 8.0% in the 6 months prior to enrollment.
- All subjects must have access to a computer.
B. Specific inclusion criteria: [Subjects could have either #1, or #2].
Subjects with clinical and biochemical features of T2DM of > 6mo duration who also have positive T1DM antibodies
- Clinical features: acanthosis nigricans, BMI >85%
- Biochemical: evidence of insulin resistance at diagnosis
- fasting insulin >27 uIU/mL(normal range 6-27) at a fasting blood glucose of ≥ 126 mg/dL, or
- fasting c-peptide level of > 7.1 ng/mL (normal range 0.9 - 7.1), or
- Homeostasis model of insulin resistance of >3.16
Patients with T1DM of > one yr duration with BMI >85%
- Presentation with ketoacidosis at diagnosis
- C-peptide <0.9 ng/mL (normal range 0.9 - 7.1),or (insulin < 6 uIU/mL) (NR 6-27) at diagnosis (when blood glucose is ≥ 126 mg/dL)
- Can be antibody positive or negative
- Increased insulin requirement (>2 Units/kg/day)
Exclusion Criteria:
- Subjects on weight altering medications, such as orlistat.
- Subjects with eating disorder
- Subjects on medications other than insulin and or metformin that may affect blood glucose level.
- Subjects with abnormal hepatic function tests.
- Subjects with nephropathy, defined in this case as an overnight albumin excretion rate of >200 mcg/min using a first morning urine sample collection.
- Subjects with recurrent diabetes ketoacidosis (more than 2 episodes in the past 12 months), or recurrent severe hypoglycemia (more than 2 episodes of hypoglycemia with altered level of consciousness, requiring assistance to treat in the past year).
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- Known or suspected allergy to metformin.
- The receipt of any investigational drug within 6 months prior to this trial.
- Active malignant neoplasms.
- No access to a computer.
- Subjects currently taking metformin for clinical purposes are not eligible to be enrolled in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
Metformin 1000 mg once daily by mouth for 9 months
|
Metformin 1000 mg once daily by mouth for 9 months
Other Names:
|
Placebo Comparator: Placebo
2 capsules once daily by mouth for 9 months
|
2 capsules once daily by mouth for 9 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Adjusted Hemoglobin A1c Over Time
Time Frame: Baseline, 3mo, 6mo, and 9 months
|
Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial.
Hemoglobin A1c is a marker of glycemic control.
The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
|
Baseline, 3mo, 6mo, and 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Adjusted Changes in Lipid Profile Over Time
Time Frame: Baseline, 3mo, 6mo, and 9 months
|
Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups.
The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
|
Baseline, 3mo, 6mo, and 9 months
|
Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time
Time Frame: Baseline, 3mo, 6 mo, and 9 months
|
Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups.
The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).
|
Baseline, 3mo, 6 mo, and 9 months
|
Number of Participants With Minor, Major, and Nocturnal Hypoglycemia
Time Frame: 12 months
|
Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin U Nwosu, MD, University of Massachusetts, Worcester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
March 21, 2011
First Submitted That Met QC Criteria
April 11, 2011
First Posted (Estimate)
April 12, 2011
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13938
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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