Phase 3
N=28
Adjunctive Metformin Therapy in Double Diabetes
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01334125 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Mar 2016
Primary outcome: Primary: Baseline Adjusted Hemoglobin A1c Over Time — 9.46; 9.85 percentage of HbA1c — p=0.903
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Worcester
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Adjusted Hemoglobin A1c Over Time |
9.46; 9.85 | 0.903 |
| SECONDARY Baseline Adjusted Changes in Lipid Profile Over Time |
3.5; 4 | 0.578 |
| SECONDARY Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time |
2.0; 1.2 | 0.057 |
| SECONDARY Number of Participants With Minor, Major, and Nocturnal Hypoglycemia |
1; 0; 3; 2; 2; 2 | 1.00 |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01334125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.