Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2006
Date assigned
07/11/2006
Last edited
16/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ramon Gomis

ORCID ID

Contact details

Endocrinology and Diabetes Unit
Hospital Clinic i Universitari
Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)
C/Villarroel
170
Barcelona
08036
Spain
gomis@medicina.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Nateglinide

Primary outcome measures

Difference in HbA1c levels between the two study groups, at 12 weeks of follow-up

Secondary outcome measures

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)

Overall trial start date

26/09/2001

Overall trial end date

25/07/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

At least 51 subjects in each study group

Participant 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

Recruitment start date

26/09/2001

Recruitment end date

25/07/2003

Locations

Countries of recruitment

Spain

Trial participating centre

Endocrinology and Diabetes Unit
Barcelona
08036
Spain

Sponsor information

Organisation

Novartis Pharma (Novartis Farmacéutica SA) (Spain)

Sponsor details

Gran Via de les Corts Catalanes
764.
Barcelona
08013
Spain
gemma.gambus@pharma.novartis.com

Sponsor type

Industry

Website

http://www.novartis.es/

Funders

Funder type

Industry

Funder name

Novartis Pharma (Spain) (ref: CDJN608AES03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (ref: RGDM 03/212)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes