DiabetesPhase 4NCT00819741
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
A Phase 4 study testing repaglinide and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 sites in China.
Trial summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- repaglinide and metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 17 sitesChina
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- Never taken oral antidiabetic drugs before
- HbA1c greater than 8.5 %
- BMI (Body Mass Index) less than or equal to 35 kg/m^2
Who cannot join
- Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
- Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
- Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
- Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
- Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
- Impaired renal function
Show all 9Show fewer
- Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
- Have a clinically significant, active cardiovascular disease, or decompensated heart failure
- Treatment with systemic corticosteroids within the past two months prior to screening
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Novo Nordisk Investigational Site
Fuzhou, Fujian, 350001
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, 310003
Novo Nordisk Investigational Site
Hangzhou, 310016
Novo Nordisk Investigational Site
Nanchang, Jiangxi, 330006
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210009
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210012
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210029
Novo Nordisk Investigational Site
Nantong, 226001
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200001
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200025
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200072
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200092
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200120
Novo Nordisk Investigational Site
Shanghai, 200040
Novo Nordisk Investigational Site
Suzhou, Jiangsu, 215004
Novo Nordisk Investigational Site
Wenzhou, Zhejiang, 325000
Novo Nordisk Investigational Site
Wuxi, Jiangsu, 214023
About this study
Official title: A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- repaglinide, metformin
- 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
The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily
metforminDrug
The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily
repaglinideDrug
The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.
| Study group | Role | What they receive |
|---|---|---|
| Repaglinide + metformin | Experimental | Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. Receives: Drug: repaglinide; Drug: metformin |
| Repaglinide | Active comparator | Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. Receives: Drug: repaglinide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin A1c (HbA1c)
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
Measured: week -2 (screening), week 16
Secondary outcomes (14)
Change in Fasting Plasma Glucose
Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.
Measured: week 0, week 16
Change in 2-hour Postprandial Plasma Glucose
Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment
Measured: Week 0, week 16
Change in 7-point Plasma Glucose Profile
Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.
Measured: Week 0, week 16
Change in Fasting Serum Insulin
Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.
Measured: Week 0, week 16
Change in 2-hour Postprandial Serum Insulin
Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.
Measured: Week 0, week 16
Change in Fasting Serum C-peptide
Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment
Measured: Week 0, week 16
Change in 2-hour Postprandial Serum C-peptide
Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment
Measured: Week 0, week 16
Hypoglycaemic Episodes
Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-16
Change in Blood Pressure
Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment
Measured: Week 0, week 16
Physical Examinations
The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.
Measured: Week -2, week 16
ECG (ElectroCardioGram)
The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Measured: Week -2, week 16
Biochemistry: Alanine Aminotransferase (ALAT)
The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Measured: Week -2, week 16
Biochemistry: Alanine Aminotransferase (ASAT)
The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Measured: Week -2, week 16
Haematology: Haemoglobin
Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Measured: Week -2, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 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
- NCT00819741
- Sponsor's protocol ID
- AGEE-3705
- Status last verified
- Dec 2016
- First submitted
- 8 Jan 2009
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang W, Bu R, Su Q, Liu J, Ning G. Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy. Expert Opin Pharmacother. 2011 Dec;12(18):2791-9. doi: 10.1517/14656566.2011.602341. Epub 2011 Jul 22.
PubMed 21780853
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00819741
- Acronym / sponsor ID
- AGEE-3705
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Posted 8 Dec 2010
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 clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repaglinide + metformin | Experimental | Drug: repaglinide, Drug: metforminInitial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. |
| Repaglinide | Active comparator | Drug: repaglinideInitial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes
- Never taken oral antidiabetic drugs before
- HbA1c greater than 8.5 %
- BMI (Body Mass Index) less than or equal to 35 kg/m^2
Key exclusion criteria (9 listed)
- Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
- Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
- Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
- Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
- Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
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 |
|---|---|---|
| repaglinideThe dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily | Drug | Repaglinide + metformin |
| metforminThe dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily | Drug | Repaglinide + metformin |
| repaglinideThe dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose. | Drug | Repaglinide |
Primary outcome
Change in Glycosylated Haemoglobin A1c (HbA1c)
Time frame: week -2 (screening), week 16
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
14 secondary outcomes
Change in Fasting Plasma Glucose
Time frame: week 0, week 16
Change in 2-hour Postprandial Plasma Glucose
Time frame: Week 0, week 16
Change in 7-point Plasma Glucose Profile
Time frame: Week 0, week 16
Change in Fasting Serum Insulin
Time frame: Week 0, week 16
Change in 2-hour Postprandial Serum Insulin
Time frame: Week 0, week 16
Change in Fasting Serum C-peptide
Time frame: Week 0, week 16
Change in 2-hour Postprandial Serum C-peptide
Time frame: Week 0, week 16
Hypoglycaemic Episodes
Time frame: Weeks 0-16
Change in Blood Pressure
Time frame: Week 0, week 16
Physical Examinations
Time frame: Week -2, week 16
ECG (ElectroCardioGram)
Time frame: Week -2, week 16
Biochemistry: Alanine Aminotransferase (ALAT)
Time frame: Week -2, week 16
Biochemistry: Alanine Aminotransferase (ASAT)
Time frame: Week -2, week 16
Haematology: Haemoglobin
Time frame: Week -2, week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21780853Wang W, Bu R, Su Q, Liu J, Ning G. Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy. Expert Opin Pharmacother. 2011 Dec;12(18):2791-9. doi: 10.1517/14656566.2011.602341. Epub 2011 Jul 22.
- 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
17 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 and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 17 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 4 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 10 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 17 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?
Yes. Results are posted in the registry (first posted 8 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glycosylated Haemoglobin A1c (HbA1c) (time frame: week -2 (screening), week 16). 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 NCT00819741, 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 10 Feb 2017.