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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004706-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
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The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This feasibility trial will inform the design of a future substantive multicentre trial to test the hypothesis that combination therapy with glibenclamide and metformin could reduce the number of pregnant women with GDM who require insulin and would be superior to metformin and insulin in terms of acceptability and cost effectiveness.
Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised to either receive glibenclamide (test arm) or standard care with insulin, both in addition to their maximum tolerated dose of metformin. Patients will be recruited from three of the antenatal clinics.
This is a feasibility study in preparation for a large multicentre randomised trial to test the hypothesis that the addition of glibenclamide to metformin (combination therapy) could reduce the number of pregnant women with gestational diabetes mellitus requiring insulin, without compromising glycaemic control or other clinical outcomes. The investigators hypothesise that combination therapy with metformin and glibenclamide is likely to be preferable to metformin and insulin in terms of acceptability and cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current Standard Care | Active Comparator | Insulin + Metformin |
|
| Treatment | Active Comparator | Glibenclamide + Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glibenclamide | Drug |
| ||
| Insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of women willing to be randomised |
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic control | Safety - number of hypoglycaemic episodes needing treatment, any other adverse events | 2 weekly |
| Patient satisfaction | assessed by visual analogue scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane E Norman, MD | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Glasgow | Glasgow | United Kingdom | |||
| Princess Royal Infirmary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28938877 | Derived | Reynolds RM, Denison FC, Juszczak E, Bell JL, Penneycard J, Strachan MWJ, Lindsay RS, Alexander CI, Love CDB, Whyte S, Mackenzie F, Stenson B, Norman JE. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial. BMC Pregnancy Childbirth. 2017 Sep 22;17(1):316. doi: 10.1186/s12884-017-1505-3. |
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|
| 36-38 weeks gestation |
| Clinical outcomes | Change in maternal weight between booking and 36 weeks | 36 weeks |
| Clinical outcome | Mode and gestation of delivery. | 40 weeks |
| Clinical Outcome | Birthweight centile (adjusted for sex and gestation at birth) | 40 weeks |
| Clinical Outcome | Incidence of neonatal hypoglycaemia (defined as any of the following: blood glucose <2.6 mmol/l) in first 48hrs age, or given intravenous glucose or any other drug to increase blood glucose) | 2 days |
| Glasgow |
| Lanarkshire |
| G31 2ER |
| United Kingdom |
| Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh | Edinburgh | Lothian | EH16 4SA | United Kingdom |
| Western General Hospital | Edinburgh | Lothian | EH4 2XU | United Kingdom |
| St Johns Hospital | Livingston | West Lothian | United Kingdom |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005905 | Glyburide |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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