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
Scientific
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 |
Study information
| 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 |
| 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 |
| 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 |
| Completion date | 25/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | At least 51 subjects in each study group |
| 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
08036
Spain
Sponsor information
Novartis Pharma (Novartis Farmacéutica SA) (Spain)
Industry
Industry
Gran Via de les Corts Catalanes, 764.
Barcelona
08013
Spain
| gemma.gambus@pharma.novartis.com | |
| Website | http://www.novartis.es/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
