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

NCT00451620 | Completed Phase 2

• 1 other identifier: H02-70584
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Hypoglycemia; Oral hypoglycemic agents; Insulin levels

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Study Arms (2)

2.

EXPERIMENTAL

GlucoNorm

Drug: GlucoNorm

1.

EXPERIMENTAL

Glyburide

Drug: glyburide

Interventions

glyburide DRUG

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.

1.

GlucoNorm DRUG

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.

2.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

Glyburide; repaglinide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Graydon Meneilly, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 23, 2007
• Study Start: November 1, 2003
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 18, 2018

Record last verified: 2018-01

Locations

CA (1)