Type 2 DiabetesPhase 2NCT00451620
Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes
A Phase 2 study testing glyburide and GlucoNorm in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- glyburide and GlucoNorm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2003to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 diabetes > 3 months duration
- Male or female
- Over 65 years of age
- Diet controlled only
- HgbA1C < 8.5%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- glyburide, GlucoNorm
- Keywords
- Type 2 diabetes, Hypoglycemia, Oral hypoglycemic agents, Insulin levels
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glyburideDrug
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.
GlucoNormDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 2. | Experimental | GlucoNorm Receives: Drug: GlucoNorm |
| 1. | Experimental | Glyburide Receives: Drug: glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startNov 2003
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Graydon Meneilly, University of British Columbia
- Investigators
- Graydon Meneilly, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451620
- Sponsor's protocol ID
- H02-70584
- Other IDs
- H02-70584
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2007
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00451620
- Acronym / sponsor ID
- H02-70584
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Hypoglycemia, Oral hypoglycemic agents, Insulin levels
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Nov 2003
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. | Experimental | Drug: GlucoNormGlucoNorm |
| 1. | Experimental | Drug: glyburideGlyburide |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes > 3 months duration
- Male or female
- Over 65 years of age
- Diet controlled only
- HgbA1C < 8.5%
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glyburideSubjects 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. | Drug | 1. |
| GlucoNormSubjects 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. | Drug | 2. |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graydon Meneilly, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glyburide and GlucoNorm in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.