AzTrials
AzTrials

Diabetes MellitusPhase 3AMTIDDNCT01334125

Adjunctive Metformin Therapy in Double Diabetes

A Phase 3 study testing Metformin in people with Diabetes Mellitus, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 10 to 20 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteUnited States
Study dates
Feb 2011to Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
  • Specific inclusion criteria: [Subjects could have either #1, or #2].
Show all 17Show fewer
  • 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)

Who cannot join

  • 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).
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UmassMemorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Metformin, Placebo
Keywords
Double Diabetes, Type 1 diabetes, Type 2 diabetes, Obesity, Acanthosis nigricans, Diabetes associated autoantibodies
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Obesity, Acanthosis Nigricans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    Metformin 1000 mg once daily by mouth for 9 months

  • PlaceboDrug

    2 capsules once daily by mouth for 9 months

Study groups in NCT01334125
Study groupRoleWhat they receive
MetforminExperimentalMetformin 1000 mg once daily by mouth for 9 months
Receives: Drug: Metformin
PlaceboPlacebo comparator2 capsules once daily by mouth for 9 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Adjusted Hemoglobin A1c Over Time

    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).

    Measured: Baseline, 3mo, 6mo, and 9 months

Secondary outcomes (3)

  1. Baseline Adjusted Changes in Lipid Profile Over Time

    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).

    Measured: Baseline, 3mo, 6mo, and 9 months

  2. Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time

    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).

    Measured: Baseline, 3mo, 6 mo, and 9 months

  3. Number of Participants With Minor, Major, and Nocturnal Hypoglycemia

    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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334125
Sponsor's protocol ID
13938
Acronym
AMTIDD
Status last verified
Mar 2016
First submitted
21 Mar 2011
Last updated
4 Mar 2016
Data monitoring committee
Yes

Publications

  • Nwosu BU, Maranda L, Cullen K, Greenman L, Fleshman J, McShea N, Barton BA, Lee MM. A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Metformin Therapy in Overweight/Obese Youth with Type 1 Diabetes. PLoS One. 2015 Sep 14;10(9):e0137525. doi: 10.1371/journal.pone.0137525. eCollection 2015.

    PubMed 26367281

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with Diabetes Mellitus, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Adjusted Hemoglobin A1c Over Time (time frame: Baseline, 3mo, 6mo, and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in