Trial · NCT01006603
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
NCT01006603, Phase 4, Completed, AstraZeneca; results first posted 2013-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin. Trials, record NCT01006603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01006603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
- NCT number
- NCT01006603
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 957 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Saxagliptin, Glimepiride
- First posted
- 2009-11-03
- Last updated
- 2013-11-28
- Results first posted
- 2013-11-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | From week 0 to week 52. | Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set. Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. |
| Secondary | Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period. | From week 0 to week 52. | Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level \<3 mmol/L (\<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement \<3 mmol/L (\<54 mg/dL). Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level \<3 mmol/L (\<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set. |
| Secondary | Change From Baseline to Week 52 in HbA1c. | From week 0 to week 52. | Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set. |
| Secondary | Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0% | From week 0 to week 52 | Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set. |
| Secondary | Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | From week 0 to week 52 | Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set. |
| Secondary | Change From Baseline to Week 52 in Insulin | From week 0 to week 52 | Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set. |
| Secondary | Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β] | From week 0 to week 52 | β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | From week 0 to week 52. | Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose). | percentage of participants | NUMBER |
| SECONDARY | Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period. | From week 0 to week 52. | Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose). | percentage of patients | NUMBER |
| SECONDARY | Change From Baseline to Week 52 in HbA1c. | From week 0 to week 52. | The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable). | % of glycosylated hemoglobin | MEAN |
| SECONDARY | Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0% | From week 0 to week 52 | The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable). | percentage of responders | NUMBER |
| SECONDARY | Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | From week 0 to week 52 | The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable). | mmol/L | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Insulin | From week 0 to week 52 | The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable). | µU/mL | MEAN |
| SECONDARY | Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β] | From week 0 to week 52 | The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable). | percentage of change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Saxagliptin 5 mg | All patients | 37.9 | percentage of participants | |
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Glimepiride 1 - 6 mg | All patients | 38.2 | percentage of participants | |
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Saxagliptin 5 mg | patients aged <75 years (n=217, n=216) | 39.2 | percentage of participants | |
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Glimepiride 1 - 6 mg | patients aged <75 years (n=217, n=216) | 33.3 | percentage of participants | |
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Saxagliptin 5 mg | patients aged ≥75 years (n=142, n=143) | 35.9 | percentage of participants | |
| Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia. | Glimepiride 1 - 6 mg | patients aged ≥75 years (n=142, n=143) | 45.5 | percentage of participants | |
| Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period. | Saxagliptin 5 mg | 1.1 | percentage of patients | ||
| Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period. | Glimepiride 1 - 6 mg | 15.3 | percentage of patients | ||
| Change From Baseline to Week 52 in HbA1c. | Saxagliptin 5 mg | -0.44 | 95% Confidence Interval -0.51 to -0.37 | % of glycosylated hemoglobin | |
| Change From Baseline to Week 52 in HbA1c. | Glimepiride 1 - 6 mg | -0.64 | 95% Confidence Interval -0.71 to -0.57 | % of glycosylated hemoglobin |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saxagliptin 5 mg | 360 | |
| Overall Study | STARTED | Glimepiride 1 - 6 mg | 360 | |
| Overall Study | COMPLETED | Saxagliptin 5 mg | 289 | |
| Overall Study | COMPLETED | Glimepiride 1 - 6 mg | 285 | |
| Overall Study | NOT COMPLETED | Saxagliptin 5 mg | 71 | |
| Overall Study | NOT COMPLETED | Glimepiride 1 - 6 mg | 75 |
Source ClinicalTrials.gov
Adverse events186
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 | VERTIGO | Ear and labyrinth disorders | Saxagliptin 5 mg | 9 | 359 | |
| other | VERTIGO | Ear and labyrinth disorders | Glimepiride 1 - 6 mg | 0 | 359 | |
| other | DIARRHOEA | Gastrointestinal disorders | Saxagliptin 5 mg | 15 | 359 | |
| other | DIARRHOEA | Gastrointestinal disorders | Glimepiride 1 - 6 mg | 19 | 359 | |
| other | CONSTIPATION | Gastrointestinal disorders | Saxagliptin 5 mg | 4 | 359 | |
| other | CONSTIPATION | Gastrointestinal disorders | Glimepiride 1 - 6 mg | 10 | 359 | |
| other | NAUSEA | Gastrointestinal disorders | Saxagliptin 5 mg | 4 | 359 | |
| other | NAUSEA | Gastrointestinal disorders | Glimepiride 1 - 6 mg | 8 | 359 | |
| other | NASOPHARYNGITIS | Infections and infestations | Saxagliptin 5 mg | 23 | 359 | |
| other | NASOPHARYNGITIS | Infections and infestations | Glimepiride 1 - 6 mg | 35 | 359 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saxagliptin 5 mg | ||
| Total, all-cause mortality | Glimepiride 1 - 6 mg | ||
| Total, other adverse events | Saxagliptin 5 mg | 130 | 359 |
| Total, other adverse events | Glimepiride 1 - 6 mg | 129 | 359 |
| Total, serious adverse events | Saxagliptin 5 mg | 41 | 359 |
| Total, serious adverse events | Glimepiride 1 - 6 mg | 32 | 359 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Saxagliptin 5 mg vs Glimepiride 1 - 6 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/NCT01006603
GET https://conductscience.org/api/trials/v1/NCT01006603/events?page=2