Back to resultsFailure Rate of GLyburide And Metformin Among Gestational Diabetics (GLAM)
Primary Purpose
Gestational Diabetes Mellitus, Class A2
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Glyburide
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus, Class A2 focused on measuring gestational diabetes, glyburide, metformin, failure rate
Eligibility Criteria
Inclusion Criteria:
We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
- 1 hour Glucose tolerance test of >130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
- A single 1 hour Glucose tolerance test value of > 200 mg/dl, and:
- Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria
Exclusion Criteria:
- - Known renal impairment.
- Known hepatic disease.
- Pre-gestational diabetes.
- Known allergy to glyburide, metformin or sulfa drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glyburide
Metformin
Arm Description
hypoglycemic agent approved for treatment of GDMA2
hypoglycemic agent approved for treatment of GDMA2
Outcomes
Primary Outcome Measures
Failure rate
need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.
Secondary Outcome Measures
Mean overall plasma glucose
average of all postprandial glucose measurements
Mean weekly fasting glucose
average of all fasting glucose measurements
preeclampsia
preeclampsia
cesarean section
mode of delivery
neonatal hypoglycemia
neonatal hypoglycemia
LGA infant
LGA infant
birthweight > 4500 grams
birthweight > 4500 grams
gestational age at birth
gestational age at birth
incidence of medication side effects
nausea, emesis, diarrhea, abdomainal bloating
Full Information
NCT ID
NCT03078725
First Posted
March 7, 2017
Last Updated
May 1, 2018
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03078725
Brief Title
Failure Rate of GLyburide And Metformin Among Gestational Diabetics
Acronym
GLAM
Official Title
Failure Rate of GLyburide And Metformin Among Gestational Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Research was competing with other projects in the department, and no patients were recruited.
Study Start Date
June 20, 2017 (Anticipated)
Primary Completion Date
March 10, 2018 (Anticipated)
Study Completion Date
May 10, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pragmatic, comparative effectiveness trial of glyburide versus metformin.
Detailed Description
Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Class A2
Keywords
gestational diabetes, glyburide, metformin, failure rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glyburide
Arm Type
Active Comparator
Arm Description
hypoglycemic agent approved for treatment of GDMA2
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
hypoglycemic agent approved for treatment of GDMA2
Intervention Type
Drug
Intervention Name(s)
Glyburide
Intervention Description
oral hypoglycemic agent
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
oral hypoglycemic agent
Primary Outcome Measure Information:
Title
Failure rate
Description
need to start insulin therapy or another hypoglycemic agent during the pregnancy to maintain normal glucose levels or need for delivery due to hyperglycemia.
Time Frame
from onset of oral therapy until delivery
Secondary Outcome Measure Information:
Title
Mean overall plasma glucose
Description
average of all postprandial glucose measurements
Time Frame
from enrollment to delivery
Title
Mean weekly fasting glucose
Description
average of all fasting glucose measurements
Time Frame
from enrollment to delivery
Title
preeclampsia
Description
preeclampsia
Time Frame
from enrollment to delivery
Title
cesarean section
Description
mode of delivery
Time Frame
from enrollment to delivery
Title
neonatal hypoglycemia
Description
neonatal hypoglycemia
Time Frame
from enrollment to delivery
Title
LGA infant
Description
LGA infant
Time Frame
from enrollment to delivery
Title
birthweight > 4500 grams
Description
birthweight > 4500 grams
Time Frame
from enrollment to deliveryfrom enrollment to delivery
Title
gestational age at birth
Description
gestational age at birth
Time Frame
from enrollment to delivery
Title
incidence of medication side effects
Description
nausea, emesis, diarrhea, abdomainal bloating
Time Frame
from enrollment to delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:
1 hour Glucose tolerance test of >130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
A single 1 hour Glucose tolerance test value of > 200 mg/dl, and:
Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria
Exclusion Criteria:
- Known renal impairment.
Known hepatic disease.
Pre-gestational diabetes.
Known allergy to glyburide, metformin or sulfa drugs.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Failure Rate of GLyburide And Metformin Among Gestational Diabetics
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