Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	University of British Columbia Novo Nordisk
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00451620

Purpose

The results from the DECODE Study have shown that postprandial (1 - 2 hours after a meal) hyperglycemia (elevated blood sugar) is more common in elderly people with diabetes than younger people with diabetes and is the best predictor of the development of complications. The DECODE Study involved 6941 people who already had diabetes and 702 who did not have diabetes. Diabetes is diagnosed when the blood sugar 1st thing in the morning is over 7.0 mmol/L. The DECODE Study showed that people at risk for diabetes can have a normal blood sugar 1st thing in the morning but have a high blood sugar 2 hours after a meal and that these people are at risk for developing heart disease and other complications of diabetes. These people would not be identified as at risk if only a fasting blood sugar is done. Studies in younger people with diabetes have shown that after a meal, insulin levels are more like a person without diabetes and glucose (blood sugar) levels are lower with GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly people with type 2 diabetes.

You have been invited to participate in this study because you have type 2 diabetes controlled by diet and/or exercise or metformin only and are over 65 years of age.

The purpose of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and glucose (blood sugar) levels after a meal in elderly people with type 2 diabetes who control their diabetes with diet and exercise.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: glyburide Drug: GlucoNorm	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Glyburide AG-EE 388 ZW

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

The objective of this study is to determine whether GlucoNorm has a greater effect than Glyburide on insulin levels and postprandial glucose levels in elderly people with type 2 diabetes who are diet controlled. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2003
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.

Detailed Description:

The results from the DECODE Study have shown that postprandial hyperglycemia is more common in elderly people with diabetes than younger people and is the best predictor of mortality and morbidity. Studies in younger people with diabetes have shown that in response to a meal, insulin profiles are more physiologic and glucose levels are lower with GlucoNorm than with Glyburide. There is no data available that demonstrates this in elderly people with type 2 diabetes.

This is a randomized, open-label, cross-over study. Subjects will undergo 2 Standard Meal Tests with Ensure 325 ml separated by 15 - 30 days. Group 1 will receive GlucoNorm 1 mg during the 1st Standard Meal Test and Glyburide 2.5 mg during the 2nd Standard Meal Test. Group 2 will receive Glyburide 2.5 mg during the 1st Standard Meal Test and GlucoNorm 1mg during the 2nd Standard Meal Test.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes > 3 months duration
Male or female
Over 65 years of age
Diet controlled only
HgbA1C < 8.5%

Exclusion Criteria:

Treatment with oral hypoglycemic agents or insulin or the likelihood of requiring treatment with these during the study.
Anemia - hgb below 130 g/L (males) and below 120 g/L (females).
Taking medications that known to interfere with glucose metabolism eg systemic corticosteriods, non-selective beta blockers.
Known or suspected allergy to glyburide, sulfa drugs or GlucoNorm impaired liver function, as shown by but not limited to AST and/or ALT > 2x the upper limit of normal.
Impaired renal function, as shown by but not limited to serum creatinine > 133 µmol/L (males) or 124 µmol/L (females).
Participated in another clinical trial within the past 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451620

Contacts

Contact: Gale Tedder, RN

604-875-4893

gtedder@interchange.ubc.ca

Locations

Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada
Contact: Gale Tedder, RN 604-875-4893 gtedder@interchange.ubc.ca
Principal Investigator: Graydon Meneilly, MD

Sponsors and Collaborators

University of British Columbia

Novo Nordisk

Investigators

Principal Investigator:

Graydon Meneilly, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Graydon Meneilly )
Study ID Numbers:	C02-0584
Study First Received:	March 21, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00451620
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Type 2 diabetes
Hypoglycemia
Oral hypoglycemic agents
Insulin levels

Study placed in the following topic categories:

Glyburide
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin
Repaglinide

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009