Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/11/2006
Date assigned
14/11/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hannele Yki-Jarvinen

ORCID ID

Contact details

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

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 measures

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, physician’s 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 subject’s 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

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

http://en.sanofi-aventis.com/

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17384341

Publication citations

  1. 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.

Additional files

Editorial Notes