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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00451620
First received: March 21, 2007
Last updated: February 17, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes

Resource links provided by NLM:


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 ]

Enrollment: 30
Study Start Date: November 2003
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.
GlucoNorm
Drug: GlucoNorm
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.
Experimental: 1.
Glyburide
Drug: glyburide
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Novo Nordisk A/S
Investigators
Principal Investigator: Graydon Meneilly, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00451620     History of Changes
Other Study ID Numbers: H02-70584, H02-70584
Study First Received: March 21, 2007
Last Updated: February 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Type 2 diabetes
Hypoglycemia
Oral hypoglycemic agents
Insulin levels

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014