DiabetesPhase 4NCT01605773
Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes
A Phase 4 study testing repaglinide and glyburide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide and glyburide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2001to 13 Mar 2003
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
- Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
- Males or non-pregnant, non-lactating females
- Subjects should have normal renal function
Who cannot join
- Type 1 or other specific causes of diabetes
- Marked symptomatic diabetes
- Uncontrolled treated/untreated hypertension
- Known or suspected allergy to the trial products or related products
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Houston, Texas, 77030
About this study
Official title: Repaglinide Versus Glyburide: Comparitive Effect on Postprandial Lipemia: An Open-labeled, Randomized, Parallel Group Study in Patients With Type 2 Diabetes
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, glyburide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repaglinideDrug
Dose individually adjusted and conducted according to labeling
glyburideDrug
Dose individually adjusted and conducted according to labeling
| Study group | Role | What they receive |
|---|---|---|
| repaglinide | Experimental | Not described Receives: Drug: repaglinide |
| glyburide | Active comparator | Not described Receives: Drug: glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride levels post standardised fat tolerance test
Secondary outcomes (3)
Incidence of hypoglycemic episodes
Change in HbA1c (glycosylated haemoglobin A1c)
Change in FPG (fasting plasma glucose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study start8 Nov 2001
- Primary completion13 Mar 2003
- Study completion13 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605773
- Sponsor's protocol ID
- AGEE-2137
- Status last verified
- Feb 2017
- First submitted
- 16 May 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repaglinide Versus Glyburide: Comparitive Effect on Postprandial Lipemia: An Open-labeled, Randomized, Parallel Group Study in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01605773
- Acronym / sponsor ID
- AGEE-2137
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2001
- Primary completion
- 13 Mar 2003 (actual)
- Study completion
- 13 Mar 2003 (actual)
- First posted
- 25 May 2012 (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.
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repaglinide | Experimental | Drug: repaglinide |
| glyburide | Active comparator | Drug: glyburide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%)
- Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%)
- Males or non-pregnant, non-lactating females
- Subjects should have normal renal function
Key exclusion criteria (4 listed)
- Type 1 or other specific causes of diabetes
- Marked symptomatic diabetes
- Uncontrolled treated/untreated hypertension
- Known or suspected allergy to the trial products or related products
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 |
|---|---|---|
| repaglinideDose individually adjusted and conducted according to labeling | Drug | repaglinide |
| glyburideDose individually adjusted and conducted according to labeling | Drug | glyburide |
Primary outcome
Triglyceride levels post standardised fat tolerance test
3 secondary outcomes
Incidence of hypoglycemic episodes
Change in HbA1c (glycosylated haemoglobin A1c)
Change in FPG (fasting plasma glucose)
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 20 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing repaglinide and glyburide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
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 4 inclusion and 4 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 20 Feb 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Triglyceride levels post standardised fat tolerance test. 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 20 Feb 2017.