Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

NCT03651531 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: 1099865-3
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM). The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.

Conditions

Gestational Diabetes

Keywords

metformin

Outcome Measures

Primary Outcomes (1)

• Hgb A1c

  Hgb A1c test

  collected at the time of delivery

Secondary Outcomes (15)

• Total daily dose of insulin

  Will be recorded on hospital admission for delivery

• Glucose control

  patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.

• Incidence of maternal hypoglycemia

  patients will be screened weekly for episodes of hypoglycemia until delivery

• Change in hemoglobin A1c over the course of the pregnancy

  hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection

• Incidence of maternal side effects

  Will be assessed weekly until delivery

Study Arms (2)

insulin

ACTIVE COMPARATOR

Drug: Insulin

insulin and metformin

ACTIVE COMPARATOR

Drug: Insulin; Drug: Metformin

Interventions

Insulin DRUG

Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester. This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.

insulin; insulin and metformin

Metformin DRUG

Will be initiated at dose of 500 mg twice daily. If glycemic control is suboptimal, the dose of metformin will be increased to 1000 mg twice a day. Metformin will be titrated prior to increases in insulin.

insulin and metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and write English and/or Spanish and give written consent
• Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:
• gram 1 hour oral diabetes screening testing yielding a result of \> 200 mg/dL
• A 100 gram 3 hour oral glucose tolerance testing yielding \>2 abnormal values (normal values defined as fasting blood glucose \< 95, 1 hour \< 180, 2 hour \< 155 and 3 hour \< 140)
• Singleton gestation
• Gestational age between 12 and 34 weeks and 6 days determined by last menstrual period (LMP) confirmed by ultrasound using criteria set forth by the ACOG (Committee on Obstetric Practice). If LMP is unknown then gestational age must be set by ultrasound prior to 20 weeks gestation.

You may not qualify if:

• Pre-existing DM either by diagnosis preceding pregnancy or hemoglobin A1c \>6.5 collected during the current pregnancy
• Uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured.
• Multiple gestations
• Major fetal anomalies anticipated to require NICU admission
• Contraindication to metformin (allergy, history of lactic acidosis, pre-existing renal disease (Cr \>1.5 mg/dL), active liver disease, current alcohol abuse).
• Vitamin B12 deficiency, as metformin reduces intestinal absorption of vitamin B12
• Medications known to effect glucose metabolism other than insulin and metformin as this may mask any effect between the two treatments.
• Known inability to tolerate metformin.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Committee Opinion No 700: Methods for Estimating the Due Date. Obstet Gynecol. 2017 May;129(5):e150-e154. doi: 10.1097/AOG.0000000000002046.

  PMID: 28426621 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Insulin; Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Christopher Nau, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

• Erika Werner

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 29, 2018
• Study Start: January 3, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)