Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(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.
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Nateglinide
Primary outcome measure
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 study start date
26/09/2001
Overall study end date
25/07/2003
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|