Diabetes Mellitus, Type 2Phase 4ENERGYNCT00928889
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
A Phase 4 study testing Nateglinide 120 mg and Acarbose 50 mg in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 6 sites in China.
Trial summary
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nateglinide 120 mg and Acarbose 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 6 sitesChina
- Study dates
- Jul 2009to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed type 2 diabetes mellitus patients
- HbA1c > 6.5 and < 9.0%
- Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control
Who cannot join
- History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
- Liver disease
- Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
People's Liberation Army. The Military General Hospital of BeiJing
Beijing, 100020
Peiking University First Hospital
Beijing, 100034
Chinese PLA General Hospital
Beijing, 100853
The First Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Guangzhou, 510080
The Second Affiliated Hospital, Zhongshan (Sun Yat-sen) University
Guangzhou, 510120
Nanfang Hospital, the Affiliated South Hospital of the Southern Medical University
Guangzhou, 510515
About this study
Official title: A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nateglinide 120 mg, Acarbose 50 mg
- Keywords
- diabetes mellitus, type 2, nateglinide, acarbose, hyperglycemia, dyslipidemias, C-reactive protein
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nateglinide 120 mgDrug
Also called Starlix
Nateglinide 120 mg was supplied as tablets.
Acarbose 50 mgDrug
Also called Glucobay
Acarbose 50 mg was supplied as tablets.
| Study group | Role | What they receive |
|---|---|---|
| Nateglinide 120 mg | Experimental | Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. Receives: Drug: Nateglinide 120 mg |
| Acarbose 50 mg | Active comparator | Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. Receives: Drug: Acarbose 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
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. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. 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 to the end of the study (Week 4)
Secondary outcomes (9)
Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
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 peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. 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 to the end of the study (Week 4)
Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
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 to the end of the study (Week 4)
Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. Total cholesterol was assessed at each study site using the same method and same reference value.
Measured: Baseline to the end of the study (Week 4)
Change From Baseline in Triglycerides at the End of the Study (Week 4)
Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. Triglycerides were assessed at each study site using the same method and same reference value.
Measured: Baseline to the end of the study (Week 4)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. LDL-C was assessed at each study site using the same method and same reference value.
Measured: Baseline to the end of the study (Week 4)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
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 4. 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 to the end of the study (Week 4)
Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. FFA was assayed at a central laboratory.
Measured: Baseline to the end of the study (Week 4)
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. 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. hsCRP was assayed at a central laboratory.
Measured: Baseline to the end of the study (Week 4)
Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. 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. GSA was assayed at a central laboratory.
Measured: Baseline to the end of the study (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionJun 2010
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 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
- 160 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
- NCT00928889
- Sponsor's protocol ID
- CDJN608ACN06
- Acronym
- ENERGY
- Status last verified
- May 2012
- First submitted
- 25 Jun 2009
- Last updated
- 10 May 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 17376293
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Active-control, Parallel-group Designed Study to Compare Effects of Nateglinide and Acarbose on Postprandial Status in Chinese Drug-naive Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00928889
- Acronym / sponsor ID
- ENERGY / CDJN608ACN06
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, type 2, nateglinide, acarbose, hyperglycemia, dyslipidemias, C-reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 7 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose fluctuation, dyslipidemia, and inflammatory status improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nateglinide 120 mg | Experimental | Drug: Nateglinide 120 mgNateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks. |
| Acarbose 50 mg | Active comparator | Drug: Acarbose 50 mgAcarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed type 2 diabetes mellitus patients
- HbA1c > 6.5 and < 9.0%
- Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control
Key exclusion criteria (4 listed)
- History of acute metabolic complications in the past 3 months or of severe diabetic complications or severe infections or active substance abuse
- Liver disease
- Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid treatment within past 4 weeks
- Other protocol-defined inclusion/exclusion criteria applied to the study.
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 |
|---|---|---|
| Nateglinide 120 mgAlso: StarlixNateglinide 120 mg was supplied as tablets. | Drug | Nateglinide 120 mg |
| Acarbose 50 mgAlso: GlucobayAcarbose 50 mg was supplied as tablets. | Drug | Acarbose 50 mg |
Primary outcome
Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
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. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. 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.
9 secondary outcomes
Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Total Cholesterol at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Triglycerides at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)
Time frame: Baseline to the end of the study (Week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
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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
6 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 120 mg and Acarbose 50 mg in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 6 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 4 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 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 7 Jul 2011). 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 From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) (time frame: Baseline to the end of the study (Week 4)). 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 NCT00928889, 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 May 2012.