Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HOE901/4041
Study information
Scientific title
Acronym
INITIATE (INITiate Insulin by Aggressive Titration and Education)
Study hypothesis
To compare initiation of insulin Individually (IND) and in Groups (GROUP) with respect to change in HbA1c and several other parameters in type two diabetic patients.
Ethics approval
Study approved by the Ethics Committee of Helsinki University Hospital (Finland) on August 15, 2003.
Study design
Multicentre multinational randomised open study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type 2 diabetes
Intervention
Insulin glargine initiated by group education versus insulin glargine initiated by teach each individual patient.
Intervention type
Drug
Phase
Not Specified
Drug names
Insulin glargine
Primary outcome measure
To determine whether insulin therapy with insulin glargine can be initiated as effectively by group education as by teaching each patient individually. Programs are defined as equally successful if the HbA1c differs less than 0.5% at the end of the study.
Secondary outcome measures
1. Cost of initiation of insulin therapy including: time spent by a nurse on education, physicians time, number and duration of phone calls
2. Change in the concentrations of serum total, High Density Lipoproteins (HDL) and Low Density Lipoproteins (LDL) cholesterol, and serum triglycerides (visit 12 versus visit three)
3. Change in body weight and blood pressure (visit 12 versus visit three)
4. Change in the fasting plasma glucose concentration (visit 12 versus visit three)
5. Insulin dose at visit 12
6. Change in subjects treatment satisfaction (measured by the Diabetes Treatment Satisfaction Questionnaire [DTSQ]) (visit 12 versus visit three)
Overall trial start date
17/11/2003
Overall trial end date
21/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female patients aged greater or equal to 18 years of age with type two diabetes
2. Treated with a stable dose (any dose) of sulfonylurea and metformin (1.5 grams or more) or either drug alone for at least six months
3. Body Mass Index (BMI) less than 45 kg/m^2
4. HbA1c between 7.0 and 12%
5. Willingness and ability to inject insulin and perform self-monitoring of blood glucose and to share some health information (glycemic control and body weight) with other members of the group
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Insulin therapy during the preceding 12 months
2. Impaired renal function, as shown by (but not limited to) serum creatinine more than 177 µmol/L (more than 2.0 mg/dL) measured at visit one or current renal dialysis
3. Gross proteinuria (dU-prot more than 3 g) at screening
4. Known acute or chronic metabolic acidosis, including diabetic ketoacidosis
5. Clinical evidence of active liver disease, or serum Alanine Aminotransferase (ALT) more than 2.5 times the upper limit of the normal range
6. History of hypoglycemia unawareness
7. Repeated (more than one) severe hypoglycemia with unconsciousness within the last year
8. Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding three months of study entry, or requiring treatment within three months after the study entry
9. Pregnancy or lactation
10. Failure to use adequate contraception (women of current reproductive potential only), e.g. use of systemic hormones (oral contraceptives or an implant), an intrauterine device, or a barrier method (diaphragm with intravaginal spermicide, cervical cap, male or female condom)
11. Known hypersensitivity to insulin glargine, or any of the excipients
12. Malignancy (except for basal cell skin cancer) within the last five years
13. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. non-cardioselective Beta-blockers, systemic corticosteroids, thiazolidinediones) months
14. Known adrenal insufficiency
15. Known haemoglobinopathy or moderate to severe anemia (i.e. hemoglobin concentration less than 110 g/dl)
16. Psychiatric condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
17. History of substance or alcohol abuse within the last two years, or current substance abuse
18. Inability to comply with study procedures
19. Any clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
20. Known positive test result for Glutamic Acid Decarboxylase (GAD), or islet cell antibodies
21. Type one Diabetes Mellitus, as defined by the World Health Organisation (WHO)
22. Use of an investigational drug during the last six months before study entry
23. Inability to stop current treatment with thiazolidinedione
Recruitment start date
17/11/2003
Recruitment end date
21/06/2005
Locations
Countries of recruitment
Finland, Netherlands, Sweden, United Kingdom
Trial participating centre
Department of Medicine
Helsinki
FIN-00029
Finland
Sponsor information
Organisation
sanofi-aventis Oy (Finland)
Sponsor details
c/o Sanni Lahdenpera
Huopalahdentie 24
Helsinki
FIN-00351
Finland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Sanofi-Aventis (Finland)
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17384341
Publication citations
-
Results
Yki-Järvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenperä S, Nijpels G, Vähätalo M, Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups., Diabetes Care, 2007, 30, 6, 1364-1369, doi: 10.2337/dc06-1357.