A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus. - Full Text View

Purpose

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: R1511 Drug: Placebo	Phase I

MedlinePlus related topics:

Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multiple-Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Glucose AUC [ Time Frame: Days -1, 1 and 8. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin, C-peptide, glucagon and GLP-1 AUC [ Time Frame: Days -1, 1 and 8 ] [ Designated as safety issue: No ]
24h glucose [ Time Frame: Days -1, 1 and 8 ] [ Designated as safety issue: No ]
Lipid profiles [ Time Frame: Days -1 and 8 ] [ Designated as safety issue: No ]
Pharmacokinetic parameters [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Experimental	Drug: R1511 Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
2: Experimental	Drug: R1511 Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
3: Experimental	Drug: R1511 Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.
4: Placebo Comparator	Drug: Placebo po bid

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-65 years of age;
type 2 diabetic patients;
naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.

Exclusion Criteria:

type 1 diabetes mellitus;
clinically significant cardiovascular disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517465

Contacts


Contact: Please reference Study ID Number: PDO_NP20945	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Locations


Germany
		Recruiting
	NEUSS, Germany, 41460
		Recruiting
	BERLIN, Germany, 14050

Hungary
		Active, not recruiting
	BUDAPEST, Hungary, 1027
		Recruiting
	BALATONFUERED, Hungary, 8230

Poland
		Not yet recruiting
	WARSAW, Poland, 02-097

Slovakia
		Recruiting
	BRATISLAVA, Slovakia, 833 05
		Completed
	BRATISLAVA, Slovakia, 82108

United Kingdom
		Completed
	SLOUGH, United Kingdom, SL1 4AA
		Active, not recruiting
	WELWYN GARDEN CITY, United Kingdom, AL7 1TW

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NP20945
First Received:	August 16, 2007
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00517465
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00517465