Adjunctive Metformin Therapy in Double Diabetes (AMTIDD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Metformin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Glycemic Control in Children and Adolescents With Double Diabetes: Trial of Optimized Insulin-Metformin Regimen |
- The proportion of subjects reaching HbA1c levels <8% at 12 months. [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
- Changes in anthropometry [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
- Changes in lipid profile [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
- Changes in adipocytokines [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
- Changes in total daily insulin requirement [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
- Assessment of the rates of hypoglycemia (blood glucose level ≤60 mg/dL) or hypoglycemic event requiring a third party assistance per subject per week. [ Time Frame: Every week for 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin
Metformin 1000 mg once daily by mouth for 9 months
|
Drug: Metformin
Metformin 1000 mg once daily by mouth for 9 months
Other Name: Glucophage
|
|
Placebo Comparator: Placebo
2 capsules once daily by mouth for 9 months
|
Drug: Placebo
2 capsules once daily by mouth for 9 months
Other Name: Placebo
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A. General inclusion criteria
- Ten to 18 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.
Contacts and Locations| Contact: Benjamin U Nwosu, MD | 508-334-7872 | benjamin.nwosu@umassmemorial.org |
| Contact: Karen Cullen, RN | 5088563329 | karen.cullen@umassmemorial.org |
| United States, Massachusetts | |
| UmassMemorial Medical Center | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: Benjamin U Nwosu, MD 508-334-7872 | |
| Contact: Karen Cullen, RN 508-856-3329 | |
| Principal Investigator: Benjamin U Nwosu, MD | |
| Sub-Investigator: Mary M Lee, MD | |
| Sub-Investigator: Louise Maranda, PhD | |
| Sub-Investigator: Leslie A Soyka, MD | |
| Sub-Investigator: Olga T Hardy, MD | |
| Sub-Investigator: Amanda Angelescu, MD | |
| Sub-Investigator: Penny Kadmon, MD | |
| Sub-Investigator: Lisa Greeenman, RD | |
| Sub-Investigator: Michael Stalvey, MD | |
| Principal Investigator: | Benjamin U Nwosu, MD | University of Massachusetts, Worcester |
More Information
No publications provided
| Responsible Party: | Benjamin U. Nwosu, Study Principle Investigator, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT01334125 History of Changes |
| Other Study ID Numbers: | 13938 |
| Study First Received: | March 21, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
Double Diabetes Type 1 diabetes Type 2 diabetes |
Obesity Acanthosis nigricans Diabetes associated autoantibodies |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013