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
Secondary identifying numbers N/A
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

Study designMulticentre, 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNateglinide 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) studiedType two diabetes mellitus with more than five years of evolution
InterventionThis study only compares Nateglinide (120 mg, three times daily) versus placebo. No other interventions were carried out nor compared.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Nateglinide
Primary outcome measureDifference in HbA1c levels between the two study groups, at 12 weeks of follow-up
Secondary outcome measuresAt 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 study start date26/09/2001
Completion date25/07/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participantsAt least 51 subjects in each study group
Key inclusion criteriaDrug-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 criteria1. 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 enrolment26/09/2001
Date of final enrolment25/07/2003

Locations

Countries of recruitment

  • Spain

Study participating centre

Endocrinology and Diabetes Unit
Barcelona
08036
Spain

Sponsor information

Novartis Pharma (Novartis Farmacéutica SA) (Spain)
Industry

Gran Via de les Corts Catalanes, 764.
Barcelona
08013
Spain

Email gemma.gambus@pharma.novartis.com
Website http://www.novartis.es/
ROR logo "ROR" https://ror.org/042e6sa59

Funders

Funder type

Industry

Novartis Pharma (Spain) (ref: CDJN608AES03)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan