DiabetesPhase 3NCT01562561
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes
A Phase 3 study testing repaglinide and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 12 sites in 5 countries.
Trial summary
This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide. 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 insulin NPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 1 Jun 2001to 20 Dec 2002
- Phase
- Phase 3
- 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
- Type 2 diabetes
- HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
- BMI (body mass index) maximum 35 kg/m^2
Who cannot join
None listed.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
South Africa6 sites
Novo Nordisk Investigational Site
Alberton, 1449
Novo Nordisk Investigational Site
Brits, North West, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7460
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Pretoria, Gauteng
Philippines3 sites
Novo Nordisk Investigational Site
Marikina City, 1800
Novo Nordisk Investigational Site
Pasig, 1605
Novo Nordisk Investigational Site
Quezon City, 1100
About this study
Official title: Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin
This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, insulin NPH
- 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
2 mg at each main meal
insulin NPHDrug
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
| Study group | Role | What they receive |
|---|---|---|
| Rep + NPH | Experimental | Not described Receives: Drug: repaglinide; Drug: insulin NPH |
| NPH | Active comparator | Not described Receives: Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Measured: Week 0 (visit 5); week 26
Secondary outcomes (4)
FPG (fasting plasma glucose)
Measured: Week 0 (visit 5); week 26
7-point blood glucose profile
Measured: Week 0 (visit 5); week 26
Hypoglycaemic episodes
Measured: Week 0 (visit 5); week 26
Adverse events
Measured: Week 0 (Visit 5); week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start1 Jun 2001
- Primary completion20 Dec 2002
- Study completion20 Dec 2002
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 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
- NCT01562561
- Sponsor's protocol ID
- AGEE-1272
- Status last verified
- Feb 2017
- First submitted
- 22 Mar 2012
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available.
PubMed 15983336
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
- Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin
- ClinicalTrials.gov ID
- NCT01562561
- Acronym / sponsor ID
- AGEE-1272
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2001 (actual)
- Primary completion
- 20 Dec 2002 (actual)
- Study completion
- 20 Dec 2002 (actual)
- First posted
- 26 Mar 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 Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rep + NPH | Experimental | Drug: repaglinide, Drug: insulin NPH |
| NPH | Active comparator | Drug: insulin NPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
- BMI (body mass index) maximum 35 kg/m^2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| repaglinide2 mg at each main meal | Drug | Rep + NPH |
| insulin NPHAdministrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner. | Drug | NPH, Rep + NPH |
Primary outcome
HbA1c (glycosylated haemoglobin)
Time frame: Week 0 (visit 5); week 26
4 secondary outcomes
FPG (fasting plasma glucose)
Time frame: Week 0 (visit 5); week 26
7-point blood glucose profile
Time frame: Week 0 (visit 5); week 26
Hypoglycaemic episodes
Time frame: Week 0 (visit 5); week 26
Adverse events
Time frame: Week 0 (Visit 5); week 26
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 publication: PubMed 15983336Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing repaglinide and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 12 sites in 5 countries.
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 3 inclusion and 0 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 12 sites in South Africa, Philippines, Hong Kong, Malaysia, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
HbA1c (glycosylated haemoglobin) (time frame: Week 0 (visit 5); week 26). 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 NCT01562561, 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.