Diabetes Mellitus, Type 2Phase 4NCT01030952
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
A Phase 4 study testing Nateglinide and Acarbose in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 3 sites in China.
Trial summary
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nateglinide and Acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2009to Feb 2011
- 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
- Patients must give written informed consent before any assessment is performed.
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
- Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
- Age in the range of 18-75 years inclusive.
- HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.
Who cannot join
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
- With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
- A history of,
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
Show all 11Show fewer
- percutaneous coronary intervention within the past 3 months.
- any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
- Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
- Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sir Run Run Shaw Hospital, 3 East Qingchun Road
Hangzhou, 310016
Shanghai Tongji Hospital, 389 Xinchun Road
Shanghai, 200065
Shanghai Sixth People's Hospital, 600 Xuanshan Road
Shanghai, 200233
About this study
Official title: A 3-week, Multi-center, Open-label, Randomized, Active-control, Parallel-group Study to Compare Effects of Nateglinide and Acarbose on Postprandial Glucose Fluctuation in Chinese Drug-naive Patients Type 2 Diabetes Mellitus
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nateglinide, Acarbose
- Keywords
- Diabetes Mellitus, Type 2, Nateglinide, Acarbose, glucose fluctuation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NateglinideDrug
Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily.
AcarboseDrug
Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Nateglinide | Experimental | Nateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. Receives: Drug: Nateglinide |
| Acarbose | Active comparator | Acarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily. Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
0-4 hours AUC were calculated using trapezoid methods.
Measured: 3 weeks (end of study) minus baseline
Secondary outcomes (14)
Change in Incremental Glucose Peak (IGP) From Baseline
Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal
Measured: baseline, 3 weeks (end of study)
Change in Mean Blood Glucose (MBG)
The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.
Measured: baseline and at 3 weeks (end of study)
Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours.
Measured: baseline, 3 weeks (end of study)
Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability.
Measured: baseline, 3 weeks (end of study)
Changes in 24 Hour Glucose Area Under Curve (AUCpp)
Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.
Measured: baseline, end of study (3 weeks)
Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments
Measured: baseline, 3 weeks (end of study)
Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes
Measured: baseline, 3 weeks (end of study)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
change in LDL-C at 0, 30 and 120 minutes
Measured: baseline, 3 weeks (end of study)
Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes
Measured: baseline, 3 weeks (end of study)
Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
TG change in blood lipids level from baseline to endpoint
Measured: baseline, 3 weeks (end of study)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.
Measured: baseline, 3 weeks (end of study)
Change in Mean Amplitude of Glycaemic Excursion (MAGE)
mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size
Measured: baseline, 3 weeks (end of study)
The Percent of 24 Hour Hypoglycemic Measurements
Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]
Measured: baseline, 3 weeks (end of study)
Change in Percent of 24 Hour Hyperglycemic Measurements
Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]
Measured: baseline, 3 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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 (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030952
- Sponsor's protocol ID
- CDJN608ACN07
- Status last verified
- Sep 2012
- First submitted
- 11 Dec 2009
- Last updated
- 19 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gao HW, Xie C, Wang HN, Lin YJ, Hong TP. Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes. Acta Pharmacol Sin. 2007 Apr;28(4):534-9. doi: 10.1111/j.1745-7254.2007.00534.x.
PubMed 17376293Zhou J, Deng Z, Lu J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Differential therapeutic effects of nateglinide and acarbose on fasting and postprandial lipid profiles: a randomized trial. Diabetes Technol Ther. 2015 Apr;17(4):229-34. doi: 10.1089/dia.2014.0299.
PubMed 25781235Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30.
PubMed 23631607
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-week, Multi-center, Open-label, Randomized, Active-control, Parallel-group Study to Compare Effects of Nateglinide and Acarbose on Postprandial Glucose Fluctuation in Chinese Drug-naive Patients Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01030952
- Acronym / sponsor ID
- CDJN608ACN07
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Nateglinide, Acarbose, glucose fluctuation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Posted 19 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nateglinide | Experimental | Drug: NateglinideNateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. |
| Acarbose | Active comparator | Drug: AcarboseAcarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal 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 (5 listed)
- Patients must give written informed consent before any assessment is performed.
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
- Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
- Age in the range of 18-75 years inclusive.
- HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.
Key exclusion criteria (11 listed)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
- With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
- A history of,
- Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
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 |
|---|---|---|
| NateglinideNateglinide tablets, oral administration, three times daily, 120 mg orally 10 minutes immediately before 3 meals three times daily. | Drug | Nateglinide |
| AcarboseAcarbose tablets, oral administration, three times daily, dosage of 50 mg orally chewing with the first bite of a meal three times daily. | Drug | Acarbose |
Primary outcome
Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)
Time frame: 3 weeks (end of study) minus baseline
The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. 0-4 hours AUC were calculated using trapezoid methods.
14 secondary outcomes
Change in Incremental Glucose Peak (IGP) From Baseline
Time frame: baseline, 3 weeks (end of study)
Change in Mean Blood Glucose (MBG)
Time frame: baseline and at 3 weeks (end of study)
Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.
Time frame: baseline, 3 weeks (end of study)
Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)
Time frame: baseline, 3 weeks (end of study)
Changes in 24 Hour Glucose Area Under Curve (AUCpp)
Time frame: baseline, end of study (3 weeks)
Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment
Time frame: baseline, 3 weeks (end of study)
Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline
Time frame: baseline, 3 weeks (end of study)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: baseline, 3 weeks (end of study)
Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point
Time frame: baseline, 3 weeks (end of study)
Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint
Time frame: baseline, 3 weeks (end of study)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study
Time frame: baseline, 3 weeks (end of study)
Change in Mean Amplitude of Glycaemic Excursion (MAGE)
Time frame: baseline, 3 weeks (end of study)
The Percent of 24 Hour Hypoglycemic Measurements
Time frame: baseline, 3 weeks (end of study)
Change in Percent of 24 Hour Hyperglycemic Measurements
Time frame: baseline, 3 weeks (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17376293Gao HW, Xie C, Wang HN, Lin YJ, Hong TP. Beneficial metabolic effects of nateglinide versus acarbose in patients with newly-diagnosed type 2 diabetes. Acta Pharmacol Sin. 2007 Apr;28(4):534-9. doi: 10.1111/j.1745-7254.2007.00534.x.
- Derived from this study: PubMed 25781235Zhou J, Deng Z, Lu J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Differential therapeutic effects of nateglinide and acarbose on fasting and postprandial lipid profiles: a randomized trial. Diabetes Technol Ther. 2015 Apr;17(4):229-34. doi: 10.1089/dia.2014.0299.
- Derived from this study: PubMed 23631607Zhou J, Li H, Zhang X, Peng Y, Mo Y, Bao Y, Jia W. Nateglinide and acarbose are comparably effective reducers of postprandial glycemic excursions in chinese antihyperglycemic agent-naive subjects with type 2 diabetes. Diabetes Technol Ther. 2013 Jun;15(6):481-8. doi: 10.1089/dia.2013.0046. Epub 2013 Apr 30.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Nateglinide and Acarbose in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals 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 5 inclusion and 11 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 19 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2012). 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 Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) (time frame: 3 weeks (end of study) minus baseline). 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 NCT01030952, which also lists 3 linked publications.
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 19 Oct 2012.