Metabolomic Variations in the Saxagliptin-Treated Type 2... | NCT01768208

Studies
Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients

NCT01768208

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Jun 14, 2016Estimated

Enrollment

569Actual

Phase

Phase 4

Conditions

Type 2 Diabetes

Interventions

Saxagliptin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Jan 14, 2013

First Posted Date

Jan 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2016

Last Update Posted Date

Jun 14, 2016Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

569Actual

Label	Type	Description	Intervention Names
Saxagliptin	Experimental		Drug: Saxagliptin

Name	Type	Description	Arm Group Labels	Other Names
Saxagliptin	Drug		Saxagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of the study is to evaluate the changes in the metabolomic parameters before and after Saxagliptin treatment in type 2 diabetic patients.	The primary objective of the study is to compare the different metabolomic profiling at baseline (before treatment) and at the end of the study drug administration(24 weeks) using a Liquid Chromatography-Mass Spectrometry (LC-MS) analysis.	24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the subject Inclusion Criteria should be referred to STUDY: D168L00008.

Briefly

Provision of informed consent prior to any study specific procedures
Diagnosed with type 2 diabetes
Men or women who are 18 years of age.
Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks.
HbA1c are between 7.5% and 11.0%

Exclusion Criteria:

All the subject Exclusion Criteria should be referred to STUDY: D168L00008.

Briefly

Pregnant or breastfeeding patients.
Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes).
Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue.
History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD).
Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed.
Treatment with strong cytochrome P450 inhibitors.
Gastrointestinal surgery that could impact the absorption of study drug.
Contraindications to therapy as outlined in the saxagliptin package insert.
Hypersensitivity to saxagliptin
Have a history of, or currently have, acute or chronic pancreatitis.
Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study.
Fasting plasma glucose >15mmol/l.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases