Observational Study on Safety of Self-titration of Once Daily Levemir®

Diabetes Mellitus, Type 2 Clinical Trial

— SOLVE™  

Official title:

Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740519
• Other study ID #: NN304-3573
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: February 2, 2017
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.

The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.

Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

• Patients unable to give written informed consent

• Current treatment with insulin

• Patient deemed unable or unwilling to self-titrate

• Known or suspected allergy to study product or related products

• Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Crawley

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Khunti K, Damci T, Meneghini L, Pan CY, Yale JF; SOLVE Study Group.. Study of Once Daily Levemir (SOLVE™): insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Diabetes Obes Metab. 2 — View Citation

Khunti K, Vora J, Davies M. Results from the UK cohort of SOLVE: providing insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Prim Care Diabetes. 2014 Apr;8(1):57-63. doi: 10.1016/ — View Citation

Ross S, Dzida G, Ji Q, Kaiser M, Ligthelm R, Meneghini L, Nazeri A, Orozco-Beltran D, Pan C, Svendsen AL; SOLVE Study Group.. Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical p — View Citation

Vora J, Caputo S, Damci T, Orozco-Beltran D, Pan C, Svendsen AL, Sølje KS, Khunti K; SOLVE study group.. Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes. J Clin Pharm Ther. 2014 Apr;39(2):136-43. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions including major hypoglycaemic events		during treatment
Secondary	Incidence of serious adverse events and all adverse events		during treatment
Secondary	Incidence of hypoglycaemic events		in the 4 weeks preceding the baseline, 12 and 20 week visits
Secondary	HbA1c		at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
Secondary	Variability and mean of the patient's self-monitored plasma glucose measurements		at approximately 12 and 20 weeks
Secondary	Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes		at approximately 12 and 20 weeks
Secondary	Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo		defined by the average of the last three FBGs
Secondary	Body weight		at approximately 12 and 20 weeks
Secondary	Frequency of insulin adjustment		at approximately 12 and 20 weeks
Secondary	Total number of visits/contacts to the clinic, related to titration		at approximately 12 and 20 weeks
Secondary	HCP time used on titration training		at baseline and approximately 12 and 20 weeks

External Links

•   Clinical Trials at Novo Nordisk