Multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial, comparing nateglinide versus placebo to assess the efficacy and tolerability of nateglinide in patients with type two diabetes mellitus

ISRCTN	ISRCTN04296019
DOI	https://doi.org/10.1186/ISRCTN04296019
Protocol serial number	N/A
Sponsor	Novartis Pharma (Novartis Farmacéutica SA) (Spain)
Funders	Novartis Pharma (Spain) (ref: CDJN608AES03), Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (ref: RGDM 03/212)

Submission date: 31/10/2006
Registration date: 07/11/2006
Last edited: 16/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ramon Gomis
Scientific

Endocrinology and Diabetes Unit
Hospital Clinic i Universitari
Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
C/Villarroel, 170
Barcelona
08036
Spain

Email	gomis@medicina.ub.es

Study information

Primary study design	Interventional
Study design	Multicentre, double-blind, parallel-group, placebo-controlled, randomised trial comparing nateglinide (120 mg, three times daily) versus placebo after a follow-up period of 12 weeks.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Nateglinide is a new oral hypoglycemic agent that increases insulin secretion. In contrast to other oral hypoglycemic agents it mainly decreases postprandial hyperglycemia and it has this effect with lower risk for hypoglycemic events. Postprandial hyperglycemia appears in the early stages with type two diabetes mellitus and we hypothesise that the use of nateglinide at these stages should improve glycemic control (in terms of HbA1c levels and postprandial hyperglycemia) without any significant increases of its adverse effects.
Ethics approval(s)	The current study received Ethical Committees approval at all the participating sites: Hospital Virgen del Rocio, Hospital Infanta Elena, Hospital Reina Sofia, C.M. Teknon, Hospital Sant Joan, Hospital Universitario de Valme, Hospital Puerta del Mar, CAP Sils, Hospital Clínic i Universitari de Barcelona, Hospital de Sabadell, CAP El Remei, Hospital de La Merced, EAP Cervera, CS Torrero Este, Unidad de Calidad de Formación, Fundació Sarda Farriol, Hospital Esperit Sant, Hospital La Macarena, Clínica Corachán, CAP Cerdenya, CS Los Comuneros, Hospital San Vicente Raspeig, CS Petrel and CAP Centelles.
Health condition(s) or problem(s) studied	Type two diabetes mellitus with more than five years of evolution
Intervention	This study only compares Nateglinide (120 mg, three times daily) versus placebo. No other interventions were carried out nor compared.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nateglinide
Primary outcome measure(s)	Difference in HbA1c levels between the two study groups, at 12 weeks of follow-up
Key secondary outcome measure(s)	At 12 weeks of follow-up: 1. Fasting plasma glucose 2. Incremental Areas Under the Curve for glucose (IAUCglucose) and C-Peptide (IAUCC-peptide) after a breakfast challenge test 3. Weight, heart rate and blood pressure 4. Haemoglobin, hematocrit and blood cell counts 5. Creatinine 6. ALT and AST levels 7. Fasting triglycerides 8. Total cholesterol 9. Homeostasis Model Assessment (HOMA)-%B (insulin secretion) and HOMA-%S (insulin sensitivity)
Completion date	25/07/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	102
Key inclusion criteria	Drug-naive 30 to 75 year old subjects with type two Diabetes Mellitus (DM) and less than five years of evolution, who met the following criteria: 1. Body Mass Index (BMI): 22 to 35 kg/m^2 2. Fasting Plasma Glucose (FPG) less than 13.3 mmol/l 3. HbA1c: 6.5 to 8.5% 4. Not taking anti-hypertensive drugs To be included, participants were in agreement neither to change their prior diet nor exercise activity during follow-up
Key exclusion criteria	1. Type one diabetes mellitus 2. Pregnancy or childbearing females not using oral contraceptives 3. Drug-abuse 4. Severe psychiatric disorders 5. Treatment with oral corticosteroids, insulin or other oral hypoglycemic agents 6. Serum creatinine more than 160 mmol/L 7. Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) more than 2.0 x Upper Limit of Normal (ULN) 8. Thyroid dysfunction 9. Fasting triglycerides more than 7.0 mmol/L 10. Total cholesterol more than 9.1 mmol/L
Date of first enrolment	26/09/2001
Date of final enrolment	25/07/2003

Locations

Countries of recruitment

Spain

Study participating centre

Endocrinology and Diabetes Unit

Barcelona
08036
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan