INITIATE (INITiate Insulin by Aggressive Titration and Education): a randomised study to compare initiation of insulin combination therapy in type two diabetic patients individually and in groups

ISRCTN	ISRCTN09079822
DOI	https://doi.org/10.1186/ISRCTN09079822
Secondary identifying numbers	HOE901/4041

Submission date: 08/11/2006
Registration date: 14/11/2006
Last edited: 25/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hannele Yki-Jarvinen
Scientific

Department of Medicine
University of Helsinki
P.O. Box 700
Helsinki
FIN-00029
Finland

Study information

Study design	Multicentre multinational randomised open study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	INITIATE (INITiate Insulin by Aggressive Titration and Education)
Study objectives	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(s)	Study approved by the Ethics Committee of Helsinki University Hospital (Finland) on August 15, 2003.
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	Insulin glargine initiated by group education versus insulin glargine initiated by teach each individual patient.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	17/11/2003
Completion date	21/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120
Key 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
Key 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
Date of first enrolment	17/11/2003
Date of final enrolment	21/06/2005

Locations

Countries of recruitment

Finland
Netherlands
Sweden
United Kingdom

Study participating centre

Department of Medicine

Helsinki
FIN-00029
Finland

Sponsor information

sanofi-aventis Oy (Finland)
Industry

c/o Sanni Lahdenpera
Huopalahdentie 24
Helsinki
FIN-00351
Finland

Website	http://en.sanofi-aventis.com/
"ROR"	https://ror.org/00tx8br33

Funders

Funder type

Industry

Sanofi-Aventis (Finland)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2007		Yes	No