tolbutamide and Diabetes Mellitus, Gestational studies

Tolbutamide: A sulphonylurea hypoglycemic agent with actions and uses similar to those of CHLORPROPAMIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290)
tolbutamide : An N-sulfonylurea that consists of 1-butylurea having a tosyl group attached at the 3-position.

Research Excerpts

Excerpt	Relevance	Reference
" Oral glucose tolerance tests (OGTTs) and frequently sampled intravenous glucose tolerance tests (FSIGTs) were conducted on Latino women with impaired glucose tolerance and a history of gestational diabetes before and after 12 weeks of treatment with 400 mg/day troglitazone (n = 13) or placebo (n = 12)."	5.09	Response of pancreatic beta-cells to improved insulin sensitivity in women at high risk for type 2 diabetes. ( Azen, SP; Berkowitz, K; Buchanan, TA; Goico, J; Kjos, SL; Marroquin, A; Ochoa, C; Peters, RK; Xiang, AH, 2000)
"We conducted a randomized placebo-controlled study to determine the effects of the thiazolidinedione compound troglitazone on whole-body insulin sensitivity (SI), pancreatic beta-cell function, and glucose tolerance in 42 Latino women with impaired glucose tolerance (IGT) and a history of gestational diabetes mellitus (GDM), characteristics that carry an 80% risk of developing NIDDM within 5 years."	5.08	Effect of troglitazone on insulin sensitivity and pancreatic beta-cell function in women at high risk for NIDDM. ( Azen, S; Berkowitz, K; Buchanan, TA; Dunn, ME; Goico, J; Kjos, SL; Marroquin, A; Peters, R; Xiang, A, 1996)
"The prevalence of pre-eclampsia was significantly increased in the group of women treated with metformin compared to women treated with sulphonylurea or insulin (32 vs."	3.70	Oral hypoglycaemic agents in 118 diabetic pregnancies. ( Damm, P; Hellmuth, E; Mølsted-Pedersen, L, 2000)
"So far, gestational diabetes treated with tolbutamide has never been associated with severe hypoglycaemia in the newborn when the mother's diabetes was well controlled."	1.30	Prolonged elimination of tolbutamide in a premature newborn with hyperinsulinaemic hypoglycaemia. ( Christesen, HB; Melander, A, 1998)

Research

Studies (6)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Glucose Area Under the Curve (AUC) Breakfast

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	3 (50.00)	18.2507
2000's	2 (33.33)	29.6817
2010's	1 (16.67)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Brown, J	1
Martis, R	1
Hughes, B	1
Rowan, J	1
Crowther, CA	1
Berkowitz, K	2
Peters, R	1
Kjos, SL	2
Goico, J	2
Marroquin, A	2
Dunn, ME	1
Xiang, A	1
Azen, S	1
Buchanan, TA	2
Fanelli, CG	1
Bolli, GB	1
Christesen, HB	1
Melander, A	1
Xiang, AH	1
Peters, RK	1
Ochoa, C	1
Azen, SP	1
Hellmuth, E	1
Damm, P	1
Mølsted-Pedersen, L	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Effect of Gain on Closed-Loop Insulin[NCT02065895]		8 participants (Actual)	Interventional	2013-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Glucose Area Under the Curve (AUC) Breakfast defines the total exposure to glucose during breakfast. Breakfast is typically considered the most difficult meal to control; low AUC is desirable.This outcome measure was analyzed for each of the three calibration error values (high error, no error and low error). (NCT02065895)
Timeframe: On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 2:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors

Nighttime Time-in-target 5.0-8.33mmol/l (Controller Set-point Plus and Minus 15 mg/dL)

Intervention	mmol/l/min (Mean)
HIGH Error	66.8
NO Error	48.8
LOW Error	37.4

Night-time in target range 5.0-8.33, following the 3 hour controller initialization period blood glucose remained at or near target. (NCT02065895)
Timeframe: On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 12:00 AM to 6:00 AM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors

Peak and Nadir Postprandial Glucose Concentration

Intervention	percentage of time in target range (Median)
HIGH Error	88
NO Errror	100
LOW Error	80

Highest and lowest glucose concentrations obtained during breakfast meal. (NCT02065895)
Timeframe: On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 12:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors

Intervention	mmol/l (Mean)
	Peak glucose concentration	Nadir glucose concentration
Gain Decreased and Target Increased	11.3	6.6
Gain Increased and Target Decreased	13.3	4.5
Nadir Mean	11.8	4.8

Article	Year
Effect of troglitazone on insulin sensitivity and pancreatic beta-cell function in women at high risk for NIDDM. Diabetes, 1996, Volume: 45, Issue:11 Topics: Adult; Blood Glucose; Blood Pressure; Body Mass Index; California; Cholesterol, HDL; Cholesterol, LD	1996
Response of pancreatic beta-cells to improved insulin sensitivity in women at high risk for type 2 diabetes. Diabetes, 2000, Volume: 49, Issue:5 Topics: Adult; Chromans; Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Glucose; Glucose Intolera	2000

Article	Year
Sulphonylureas and pregnancy. European journal of endocrinology, 1998, Volume: 138, Issue:6 Topics: Diabetes, Gestational; Female; Half-Life; Humans; Hypoglycemic Agents; Maternal-Fetal Exchange; Preg	1998
Prolonged elimination of tolbutamide in a premature newborn with hyperinsulinaemic hypoglycaemia. European journal of endocrinology, 1998, Volume: 138, Issue:6 Topics: Adult; Diabetes, Gestational; Female; Half-Life; Humans; Hyperinsulinism; Hypoglycemia; Hypoglycemic	1998
Oral hypoglycaemic agents in 118 diabetic pregnancies. Diabetic medicine : a journal of the British Diabetic Association, 2000, Volume: 17, Issue:7 Topics: Abruptio Placentae; Adult; Birth Weight; Cesarean Section; Cohort Studies; Diabetes Mellitus, Type 2	2000

tolbutamide and Diabetes Mellitus, Gestational