Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000390583
Ethics application status
Approved
Date submitted
3/08/2006
Date registered
5/09/2006
Date last updated
5/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
PHX1149 in Patients With Type 2 Diabetes Mellitus
Scientific title
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Postprandial Blood Glucose, Safety and Establish Proof of Concept With PHX1149 in Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 304 0
Phenomix Corporation, USA: PHX1149-PROT201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 1356 0
Condition category
Condition code
Metabolic and Endocrine 1447 1447 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test a 4-week treatment course of the investigational drug, PHX1149, at doses of 100mg, 200mg or 400mg, orally once daily, in patients with Type 2 diabetes mellitus.
Intervention code [1] 1237 0
Treatment: Drugs
Comparator / control treatment
The control group will receive matching placebo, orally once daily, for four weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 1998 0
Postprandial blood glucose
Timepoint [1] 1998 0
On study Days 1 and 28.
Secondary outcome [1] 3459 0
Fasting blood glucose and insulin
Timepoint [1] 3459 0
Throughout the 28-day study period
Secondary outcome [2] 3460 0
Plasma insulin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide, gastric inhibitory peptide (GIP) and glucagon levels, and peak postprandial glucose.
Timepoint [2] 3460 0
On study Days 1 and 28.
Secondary outcome [3] 3461 0
Plasma PHX1149 levels and percent ex vivo Dipeptidyl peptidase 4 (DPP4) inhibition.
Timepoint [3] 3461 0
On study Day 28.

Eligibility
Key inclusion criteria
Body mass index (BMI) 25 to 40 kg/m2, inclusive; Type 2 diabetes mellitus; current treatment of Type 2 diabetes mellitus = 1500 mg/day of metformin or highest tolerated dose for at least 4 weeks prior to Screening visit; fasting plasma glucose of 118 – 220 mg/dL, inclusive; HbA1c (which reflects average blood glucose level over the past 2-3 months) 7.5% - 9.5%, inclusive; and a fasting plasma C-peptide greater than 0.26 nmol/L at screening; no Type 1 diabetes mellitus or marked diabetic long-term complications.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MODY (Mature Onset Diabetes of the Young), insulin dependent type 2 diabetes mellitus, or other unusual or rare forms of diabetes Mellitus; epilepsy; history of diabetic coma or severe hypoglycemic episode during the 6 months prior to screening; history of stroke, myocardial infarction, symptomatic coronary artery disease, angina, congestive heart failure, or arrhythmia during the 12 months prior to screening; inadequately controlled hypertension; gastrointestinal surgery for obesity; current efforts to lose weight; current administration of anti-psychotic medications, products intended to stimulate appetite, central stimulants, androgens, or growth hormone; administration within the past 2 weeks of systemic glucocorticoids; uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric, or urogenital disorder; diseases of the skin and its appendages, the eyes, ears, nose, or throat; malignancy within the past 5 years; HIV, Hepatitis B, or Hepatitis C; history of alcohol or substance abuse in the past 2 years or an eating disorder in the past 5 years; use of any investigational drug or participation in any investigational study within 30 days prior to screening; relevant laboratory abnormalities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not mandatory
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment outside Australia
Country [1] 383 0
United States of America
State/province [1] 383 0

Funding & Sponsors
Funding source category [1] 1585 0
Commercial sector/Industry
Name [1] 1585 0
Phenomix Corporation
Country [1] 1585 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Phenomix Corporation, USA
Address
Country
United States of America
Secondary sponsor category [1] 1392 0
Commercial sector/Industry
Name [1] 1392 0
Novotech (Australia) Pty Ltd
Address [1] 1392 0
Country [1] 1392 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36306 0
Address 36306 0
Country 36306 0
Phone 36306 0
Fax 36306 0
Email 36306 0
Contact person for public queries
Name 10426 0
Serena King
Address 10426 0
Novotech (Australia) Pty Ltd
19 Harris Street
Pyrmont NSW 2009
Country 10426 0
Australia
Phone 10426 0
+61 2 95189600
Fax 10426 0
Email 10426 0
[email protected]
Contact person for scientific queries
Name 1354 0
Hans-Peter Guler M.D.
Address 1354 0
Phenomix Corporation
Suite 200
5871 Oberlin Drive
San Diego CA 92121
Country 1354 0
United States of America
Phone 1354 0
0011 1 858 731 5212
Fax 1354 0
Email 1354 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.