Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01301456 · ClinicalTrials.gov registry record · Phase 1
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
A Phase 1 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 7
- Study locations
NCT01301456: Completed Phase 1 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, sponsored by Pfizer.
NCT01301456 is a Phase 1 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus that has completed, run by Pfizer. The registered enrollment target is 84 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01301456, a Phase 1 study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Primary Outcome
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 28 days
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL PF-04856883
Study Locations (7)
Florida
- Elite Research Institute - Miami
- Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) - Miramar
California
- Profil Institute for Clinical Research, Inc. - Chula Vista
Georgia
- Atlanta Center for Medical Research - Atlanta
Nebraska
- ICON Clinical Pharmacology, LLC - Omaha
Pennsylvania
- CRI Worldwide, LLC - Philadelphia
Texas
- Healthcare Discoveries LLC d/b/a ICON Development Solutions - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01301456 record still lists
NCT01301456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01301456 lists 7 locations in 6 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT01301456 about?
NCT01301456 is a clinical study titled "Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females". The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
What is the current status of trial NCT01301456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2011-03. Estimated completion is 2012-04.
What conditions does trial NCT01301456 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases.
What interventions are being tested in trial NCT01301456?
The interventions under investigation include: Placebo (BIOLOGICAL), PF-04856883 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01301456?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01301456 being conducted?
This trial has 7 study locations across California, Florida, Georgia, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01301456's enrollment target sits among peer trials
84 214th of 348 higher than 135 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
RECRUITING · Phase 1
-
Multiple Dose Study of MK-2828 in Participants With Type 2 Diabetes (MK-2828-003)
RECRUITING · Phase 1
-
Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
ACTIVE NOT RECRUITING · Phase 1
-
Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
ACTIVE NOT RECRUITING · Phase 1
-
A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults
ACTIVE NOT RECRUITING · Phase 1
-
Multiple Dose Safety Toelrability, Pharmacokinetics and Midazolam Interaction In Healthy Overweight And Obese Subjects
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02391519 · 84 participants
Effects of High Altitude on AMPK Activation
- NCT03838536 · 84 participants · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
- NCT03884075 · 84 participants · Phase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- NCT03894917 · 84 participants
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia