DiabetesPhase 4NCT01698931
Efficacy of Repaglinide in Subjects With 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 Italy.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide and glyburide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2002to 6 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1c (glycosylated haemoglobin A1c) above 7 %
- BMI (body mass index) below 32 kg/m^2
- FBG (fasting blood glucose) after wash out period 130-220 mg/dl
- Currently treated with diet or OHA (oral hypoglycaemic agent)
Who cannot join
- Current systemic treatment with concomitant medication
- Known or suspected history of drug or alcohol dependence
- Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
- Hepatic disease
- Cardiac problems
- Active proliferative retinopathy
Show all 9Show fewer
- Known or suspected allergy to trial product or related products
- Women in fertile age and women having the intention of becoming pregnant
- Body Mass Index (BMI) above 32 kg/m^2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, glyburide, placebo
- 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
1 mg before each main meal on three separate dosing visits separated by a wash-out period
glyburideDrug
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
placeboDrug
Before each main meal on three separate dosing visits separated by a wash-out period
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | Not described Receives: Drug: repaglinide; Drug: glyburide; Drug: placebo |
| Treatment period 2 | Active comparator | Not described Receives: Drug: repaglinide; Drug: glyburide; Drug: placebo |
| Treatment period 3 | Placebo comparator | Not described Receives: Drug: repaglinide; Drug: glyburide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal hepatic glucose production
Measured: Day 0; day 44
Secondary outcomes (3)
Number of hypoglycaemic episodes
Measured: Day 0; day 44
Change in body weight
Measured: Day 0; day 44
Number of adverse events
Measured: Day 0; day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study start26 Apr 2002
- Primary completion6 Mar 2003
- Study completion6 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT01698931
- Sponsor's protocol ID
- AGEE-1259
- Status last verified
- Feb 2017
- First submitted
- 1 Oct 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)
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
- Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01698931
- Acronym / sponsor ID
- AGEE-1259
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2002 (actual)
- Primary completion
- 6 Mar 2003 (actual)
- Study completion
- 6 Mar 2003 (actual)
- First posted
- 3 Oct 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 Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: repaglinide, Drug: glyburide, Drug: placebo |
| Treatment period 2 | Active comparator | Drug: repaglinide, Drug: glyburide, Drug: placebo |
| Treatment period 3 | Placebo comparator | Drug: repaglinide, Drug: glyburide, Drug: placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- HbA1c (glycosylated haemoglobin A1c) above 7 %
- BMI (body mass index) below 32 kg/m^2
- FBG (fasting blood glucose) after wash out period 130-220 mg/dl
- Currently treated with diet or OHA (oral hypoglycaemic agent)
Key exclusion criteria (9 listed)
- Current systemic treatment with concomitant medication
- Known or suspected history of drug or alcohol dependence
- Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
- Hepatic disease
- Cardiac problems
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 |
|---|---|---|
| repaglinide1 mg before each main meal on three separate dosing visits separated by a wash-out period | Drug | Treatment period 1, Treatment period 2, Treatment period 3 |
| glyburide5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period | Drug | Treatment period 1, Treatment period 2, Treatment period 3 |
| placeboBefore each main meal on three separate dosing visits separated by a wash-out period | Drug | Treatment period 1, Treatment period 2, Treatment period 3 |
Primary outcome
Basal hepatic glucose production
Time frame: Day 0; day 44
3 secondary outcomes
Number of hypoglycaemic episodes
Time frame: Day 0; day 44
Change in body weight
Time frame: Day 0; day 44
Number of adverse events
Time frame: Day 0; day 44
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.
- Results publicationCiccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1): A284 (Abstract No. PS65-781)
- 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 Italy.
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 9 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 Italy. 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. Some participants in this study may receive a placebo. 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?
Basal hepatic glucose production (time frame: Day 0; day 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698931, which also lists 1 linked publication.
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.