Trial · NCT01792635
A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
NCT01792635, Phase 2, Terminated, Pfizer; results first posted 2017-02-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus. Trials, record NCT01792635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01792635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
- NCT number
- NCT01792635
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- PF-05175157, Placebo
- First posted
- 2013-02-15
- Last updated
- 2017-02-16
- Results first posted
- 2017-02-16
- Limitations and caveats
Part B of the study was terminated due to the safety issue. Due to the low number of participants who completed the study, there are no conclusions for PK or PD in Part B. The prioritization of Part A endpoints was done by inputs from team.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glucose Infusion Rates (GIR) in Part A | 1 day | GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively. |
| Primary | Endogenous Gucose Production (EGP) in Part A | 1 day | EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity). |
| Primary | [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A | 1 day | \[6,6-2H2\] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. |
| Primary | Rate of Appearance of Glucose (Ra) in Part A | 1 day | Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2). |
| Primary | Whole-body Glucose Uptake in Part A | 1 day | Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp |
| Primary | Whole-body Glucose Uptake in Part B in Placebo Group | 6 weeks | Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp |
| Primary | Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group | 6 weeks | Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B | Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. |
| Primary | Number of Participants With Laboratory Test Abnormalities in Part B | Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) | Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone \[FSH\], urine drug screen, lipid profile and very-low-density lipoproteins \[VLDL\], hemoglobin A1c \[HbA1c\], C-peptide, thyroid-stimulating hormone \[TSH\], Hepatitis B and C, human immunodeficiency virus \[HIV\], triglycerides, urine creatinine). |
| Primary | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B | Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) | Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (\<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (\>=)30 mm Hg, sitting diastolic blood pressure (DBP) of \<50 mm Hg or change in sitting DBP of \>=20 mm Hg, sitting pulse rate of \<40 or greater than (\>) 120 beats per minute (bpm). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glucose Infusion Rates (GIR) in Part A | 1 day | All participants randomized and who had at least one euglycemic hyperinsulinemic clamp | mg/min | MEAN |
| PRIMARY | Endogenous Gucose Production (EGP) in Part A | 1 day | All participants randomized and who had at least one euglycemic hyperinsulinemic clamp | mg/kilogram (kg) body weight (BW)/min | MEDIAN |
| PRIMARY | [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A | 1 day | All participants randomized and who had at least one euglycemic hyperinsulinemic clamp | percentage enrichment of plasma glucose | MEAN |
| PRIMARY | Rate of Appearance of Glucose (Ra) in Part A | 1 day | All participants randomized and who had at least one euglycemic hyperinsulinemic clamp. | mg/kg BW/min | MEAN |
| PRIMARY | Whole-body Glucose Uptake in Part A | 1 day | All participants randomized and who had at least one euglycemic hyperinsulinemic clamp. | mg/kg BW/min | MEAN |
| PRIMARY | Whole-body Glucose Uptake in Part B in Placebo Group | 6 weeks | Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B. | mg/kg BW/min | MEAN |
| PRIMARY | Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group | 6 weeks | Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B. | mg/kg BW/min | MEAN |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B | Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration) | All participants who were admitted to the clinical research unit (CRU) on Day -5 | Participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities in Part B | Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) | All participants who were admitted to the Clinical Research Unit (CRU) on Day -5 | Participants | NUMBER |
| PRIMARY | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B | Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) | All participants who were admitted to the CRU on Day -5 | Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glucose Infusion Rates (GIR) in Part A | All Participants in Part A | Clamp 1 GIR1 | 191 | 90% Confidence Interval 153 to 229 | mg/min |
| Glucose Infusion Rates (GIR) in Part A | All Participants in Part A | Clamp 1 GIR2 | 780 | 90% Confidence Interval 580 to 980 | mg/min |
| Glucose Infusion Rates (GIR) in Part A | All Participants in Part A | Clamp 2 GIR1 | 152 | 90% Confidence Interval 132 to 172 | mg/min |
| Endogenous Gucose Production (EGP) in Part A | All Participants in Part A | Clamp 1 EGP0 | 1.79 | Full Range 1.48 to 1.99 | mg/kilogram (kg) body weight (BW)/min |
| Endogenous Gucose Production (EGP) in Part A | All Participants in Part A | Clamp 1 EGP1 | 0.85 | Full Range 0.51 to 0.98 | mg/kilogram (kg) body weight (BW)/min |
| Endogenous Gucose Production (EGP) in Part A | All Participants in Part A | Clamp 1 EGP2 | 0.07 | Full Range -0.02 to 0.36 | mg/kilogram (kg) body weight (BW)/min |
| Endogenous Gucose Production (EGP) in Part A | All Participants in Part A | Clamp 2 EGP0 | 1.68 | Full Range 1.59 to 1.89 | mg/kilogram (kg) body weight (BW)/min |
| Endogenous Gucose Production (EGP) in Part A | All Participants in Part A | Clamp 2 EGP1 | 0.81 | Full Range 0.71 to 0.98 | mg/kilogram (kg) body weight (BW)/min |
| [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A | All Participants in Part A | Clamp 1 | 2.96 | 90% Confidence Interval 2.94 to 2.98 | percentage enrichment of plasma glucose |
| [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A | All Participants in Part A | Clamp 2 | 2.97 | 90% Confidence Interval 2.88 to 3.06 | percentage enrichment of plasma glucose |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | All Participants in Part A | 6 | |
| Part A | STARTED | Placebo - Part B | 0 | |
| Part A | STARTED | PF-05175157 200 mg Twice a Day - Part B | 0 | |
| Part A | COMPLETED | All Participants in Part A | 6 | |
| Part A | COMPLETED | Placebo - Part B | 0 | |
| Part A | COMPLETED | PF-05175157 200 mg Twice a Day - Part B | 0 | |
| Part A | NOT COMPLETED | All Participants in Part A | 0 | |
| Part A | NOT COMPLETED | Placebo - Part B | 0 | |
| Part A | NOT COMPLETED | PF-05175157 200 mg Twice a Day - Part B | 0 | |
| Part B | STARTED | All Participants in Part A | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events24
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 | Lacrimation increased | Eye disorders | All Participants in Part A | 0 | 6 | |
| other | Lacrimation increased | Eye disorders | PF-05175157 200 mg Twice a Day - Part B | 1 | 7 | |
| other | Lacrimation increased | Eye disorders | Placebo - Part B | 0 | 6 | |
| other | Constipation | Gastrointestinal disorders | All Participants in Part A | 0 | 6 | |
| other | Constipation | Gastrointestinal disorders | PF-05175157 200 mg Twice a Day - Part B | 1 | 7 | |
| other | Constipation | Gastrointestinal disorders | Placebo - Part B | 0 | 6 | |
| other | Upper respiratory tract infection | Infections and infestations | All Participants in Part A | 0 | 6 | |
| other | Upper respiratory tract infection | Infections and infestations | PF-05175157 200 mg Twice a Day - Part B | 1 | 7 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo - Part B | 0 | 6 | |
| other | Decreased appetite | Metabolism and nutrition disorders | All Participants in Part A | 0 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants in Part A | ||
| Total, all-cause mortality | PF-05175157 200 mg Twice a Day - Part B | ||
| Total, all-cause mortality | Placebo - Part B | ||
| Total, other adverse events | All Participants in Part A | 0 | 6 |
| Total, other adverse events | PF-05175157 200 mg Twice a Day - Part B | 5 | 7 |
| Total, other adverse events | Placebo - Part B | 1 | 6 |
| Total, serious adverse events | All Participants in Part A | 0 | 6 |
| Total, serious adverse events | PF-05175157 200 mg Twice a Day - Part B | 1 | 7 |
| Total, serious adverse events | Placebo - Part B | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| PF-05175157 200 mg Twice a Day - Part B vs Placebo - Part B: Number of Participants With Laboratory Test Abnormalities in Part B |
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/NCT01792635
GET https://conductscience.org/api/trials/v1/NCT01792635/results?page=2