DiabetesPhase 4NCT01720303
Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes
A Phase 4 study testing repaglinide, isophane human insulin and insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in China.
Trial summary
This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide, isophane human insulin and insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 3 sitesChina
- Study dates
- 19 Sep 2002to 10 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c between 7.5 % and 13.0% (both inclusive)
- Fasting C-peptide above or equal to 0.33 nmol/l
- BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)
Who cannot join
- Medical history of treatment with insulin within the last 6 months
- Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
Trial locations and contacts
3 sites in 1 country.
China3 sites
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100101
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200040
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy
This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, isophane human insulin, insulin
- 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 (tablets) before each main meal
isophane human insulinDrug
Injection s.c. (under the skin) at bedtime
insulinDrug
Injection s.c. (under the skin) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Rep + NPH | Experimental | Not described Receives: Drug: repaglinide; Drug: isophane human insulin |
| Premixed insulin/NPH | Active comparator | Not described Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Secondary outcomes (2)
Change in FBG (Fasting Blood Glucose)
Change in body weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study start19 Sep 2002
- Primary completion10 Apr 2003
- Study completion10 Apr 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
- 159 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
- NCT01720303
- Sponsor's protocol ID
- AGEE-3020
- Status last verified
- Feb 2017
- First submitted
- 31 Oct 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
- A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy
- ClinicalTrials.gov ID
- NCT01720303
- Acronym / sponsor ID
- AGEE-3020
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2002 (actual)
- Primary completion
- 10 Apr 2003 (actual)
- Study completion
- 10 Apr 2003 (actual)
- First posted
- 2 Nov 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. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.
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: isophane human insulin |
| Premixed insulin/NPH | Active comparator | Drug: insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HbA1c between 7.5 % and 13.0% (both inclusive)
- Fasting C-peptide above or equal to 0.33 nmol/l
- BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)
Key exclusion criteria (2 listed)
- Medical history of treatment with insulin within the last 6 months
- Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
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 (tablets) before each main meal | Drug | Rep + NPH |
| isophane human insulinInjection s.c. (under the skin) at bedtime | Drug | Rep + NPH |
| insulinInjection s.c. (under the skin) twice daily | Drug | Premixed insulin/NPH |
Primary outcome
Change in HbA1c
2 secondary outcomes
Change in FBG (Fasting Blood Glucose)
Change in body weight
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.
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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
3 sites 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, isophane human insulin and insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in China.
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 2 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 3 sites in China. 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?
Change in HbA1c. 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.