Trial · NCT01517373
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
NCT01517373, Phase 2, Completed, Pfizer; results first posted 2017-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin. Trials, record NCT01517373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01517373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
- NCT number
- NCT01517373
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 304 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Placebo, PF-04937319 10 mg, PF-04937319 50 mg, PF-04937319 100 mg, Glimepiride
- First posted
- 2012-01-25
- Last updated
- 2017-01-31
- Other registries' IDs
- eudract:2011-005206-30
- Results first posted
- 2017-01-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | Baseline (Day 1), Week 12 | HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 | Baseline (Day 1), Week 2, 4, 6, 8 | HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported. |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 | Baseline (Day 1), Week 2, 4, 6, 8, 12 | |
| Secondary | Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 | Week 12 | HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent. |
| Secondary | Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data | Baseline (Day 1) up to Week 14 | Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to \[\>=\] 25/50% \[if baseline value was \>200 then percent change of \>25% counts; if baseline value was \<=200 then percent change of \>50% counts\]); QRS complex (percent change of \>=50%); QT Fridericia's correction (QTcF) interval (change of \>= 30 to \<60 millisecond \[msec\], and change of \>=60 msec). |
| Secondary | Number of Participants With Increase/Decrease From Baseline Vital Signs Data | Baseline (Day 1) up to Week 14 | Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of \>=30 millimeter of mercury (mmHg); sitting diastolic BP of \>=20 mmHg and pulse rate was based on investigator's discretion. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Secondary | Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode | Baseline (Day 1) up to Week 14 | A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =\< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =\<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =\<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =\<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers. |
| Secondary | Number of Hypoglycemic Events (HAE) Episodes Per Participant | Baseline (Day 1) up to Week 14 | A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported. |
| Secondary | Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant | Baseline (Day 1) up to Week 14 | Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Glycosylated Hemoglobin (HbA1C) at Week 12 | Baseline (Day 1), Week 12 | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group. | percentage of hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 | Baseline (Day 1), Week 2, 4, 6, 8 | FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected. | percentage of hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 | Baseline (Day 1), Week 2, 4, 6, 8, 12 | FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 | Week 12 | FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Increase/Decrease From Baseline Vital Signs Data | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days) | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Hypoglycemic Events (HAE) Episodes Per Participant | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | events per participant | MEDIAN |
| SECONDARY | Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant | Baseline (Day 1) up to Week 14 | Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group165
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 Glycosylated Hemoglobin (HbA1C) at Week 12 | Placebo | Baseline (n=59, 57, 55, 60, 60) | 7.90 | Standard Deviation 0.988 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 10 mg | Baseline (n=59, 57, 55, 60, 60) | 7.97 | Standard Deviation 0.886 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 50 mg | Baseline (n=59, 57, 55, 60, 60) | 7.91 | Standard Deviation 0.987 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 100 mg | Baseline (n=59, 57, 55, 60, 60) | 7.88 | Standard Deviation 0.969 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | Glimepiride | Baseline (n=59, 57, 55, 60, 60) | 8.12 | Standard Deviation 0.884 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | Placebo | Change at Week 12 (n=56, 53, 53, 54, 54) | -0.13 | Standard Deviation 0.789 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 10 mg | Change at Week 12 (n=56, 53, 53, 54, 54) | -0.18 | Standard Deviation 0.804 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 50 mg | Change at Week 12 (n=56, 53, 53, 54, 54) | -0.45 | Standard Deviation 0.733 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | PF-04937319 100 mg | Change at Week 12 (n=56, 53, 53, 54, 54) | -0.64 | Standard Deviation 0.797 | percentage of hemoglobin |
| Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | Glimepiride | Change at Week 12 (n=56, 53, 53, 54, 54) | -1.01 | Standard Deviation 0.709 | percentage of hemoglobin |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period | STARTED | Metformin 500 mg | 361 | |
| Run-in Period | STARTED | Placebo | 0 | |
| Run-in Period | STARTED | PF-04937319 10 mg | 0 | |
| Run-in Period | STARTED | PF-04937319 50 mg | 0 | |
| Run-in Period | STARTED | PF-04937319 100 mg | 0 | |
| Run-in Period | STARTED | Glimepiride | 0 | |
| Run-in Period | COMPLETED | Metformin 500 mg | 304 | |
| Run-in Period | COMPLETED | Placebo | 0 | |
| Run-in Period | COMPLETED | PF-04937319 10 mg | 0 | |
| Run-in Period | COMPLETED | PF-04937319 50 mg | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,080
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 | Anaemia | Blood and lymphatic system disorders | Metformin 500 mg | 0 | 361 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 61 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04937319 10 mg | 0 | 60 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04937319 50 mg | 2 | 61 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-04937319 100 mg | 0 | 61 | |
| other | Anaemia | Blood and lymphatic system disorders | Glimepiride | 0 | 61 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Metformin 500 mg | 0 | 361 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 0 | 61 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-04937319 10 mg | 1 | 60 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PF-04937319 50 mg | 0 | 61 |
1 to 10 of 1,080Source ClinicalTrials.gov
See all 1,080 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin 500 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PF-04937319 10 mg | ||
| Total, all-cause mortality | PF-04937319 50 mg | ||
| Total, all-cause mortality | PF-04937319 100 mg | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | Metformin 500 mg | 63 | 361 |
| Total, other adverse events | Placebo | 26 | 61 |
| Total, other adverse events | PF-04937319 10 mg | 28 | 60 |
| Total, other adverse events | PF-04937319 50 mg | 31 | 61 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25885172 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01517373
GET https://conductscience.org/api/trials/v1/NCT01517373/results?page=2