Trial · NCT00928889
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
NCT00928889, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2011-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors. Trials, record NCT00928889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00928889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
- NCT number
- NCT00928889
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 160 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Nateglinide 120 mg, Acarbose 50 mg
- First posted
- 2009-06-26
- Last updated
- 2012-05-10
- Results first posted
- 2011-07-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) | 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. |
| Secondary | Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4) | 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. 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. |
| Secondary | Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4) | 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. 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. |
| Secondary | Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in Triglycerides at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4) | Baseline to 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. |
| Secondary | Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4) | Baseline to 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol*min/L | MEAN |
| SECONDARY | Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Triglycerides at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4) | Baseline to the end of the study (Week 4) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) | Nateglinide 120 mg | -1.775 | Standard Deviation 1.3618 | mmol/L | |
| Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4) | Acarbose 50 mg | -2.434 | Standard Deviation 1.4418 | mmol/L | |
| Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4) | Nateglinide 120 mg | -2.350 | Standard Deviation 1.8480 | mmol/L | |
| Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4) | Acarbose 50 mg | -3.129 | Standard Deviation 1.8151 | mmol/L | |
| Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4) | Nateglinide 120 mg | -217.628 | Standard Deviation 179.8929 | mmol*min/L | |
| Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4) | Acarbose 50 mg | -278.447 | Standard Deviation 171.2480 | mmol*min/L | |
| Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Nateglinide 120 mg | Fasting, N=74, 77 | 0.015 | Standard Deviation 0.742 | mmol/L |
| Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Acarbose 50 mg | Fasting, N=74, 77 | -0.149 | Standard Deviation 1.050 | mmol/L |
| Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Nateglinide 120 mg | 120 minutes, N=74, 76 | 0.010 | Standard Deviation 0.700 | mmol/L |
| Change From Baseline in Total Cholesterol at the End of the Study (Week 4) | Acarbose 50 mg | 120 minutes, N=74, 76 | -0.059 | Standard Deviation 0.682 | mmol/L |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nateglinide 120 mg | 80 | |
| Overall Study | STARTED | Acarbose 50 mg | 80 | |
| Overall Study | COMPLETED | Nateglinide 120 mg | 75 | |
| Overall Study | COMPLETED | Acarbose 50 mg | 78 | |
| Overall Study | NOT COMPLETED | Nateglinide 120 mg | 5 | |
| Overall Study | NOT COMPLETED | Acarbose 50 mg | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Nateglinide 120 mg | 1 | 80 | |
| other | Abdominal distension | Gastrointestinal disorders | Acarbose 50 mg | 4 | 80 | |
| other | Flatulence | Gastrointestinal disorders | Nateglinide 120 mg | 1 | 80 | |
| other | Flatulence | Gastrointestinal disorders | Acarbose 50 mg | 4 | 80 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Nateglinide 120 mg | 4 | 80 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Acarbose 50 mg | 1 | 80 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nateglinide 120 mg | ||
| Total, all-cause mortality | Acarbose 50 mg | ||
| Total, other adverse events | Nateglinide 120 mg | 5 | 80 |
| Total, other adverse events | Acarbose 50 mg | 7 | 80 |
| Total, serious adverse events | Nateglinide 120 mg | 0 | 80 |
| Total, serious adverse events | Acarbose 50 mg | 0 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17376293 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nateglinide 120 mg vs Acarbose 50 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00928889
GET https://conductscience.org/api/trials/v1/NCT00928889/results?page=2