Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SOLVE™  

Official title:

A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825643
• Other study ID #: NN304-3714
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: February 10, 2017
• Start date: April 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, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice.

Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18481
• 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's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

• Current treatment with insulin

• Known or suspected allergy to Levemir® or excipients

• Children below the age of 6 years

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

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
Canada	Novo Nordisk Investigational Site	Mississauga
China	Novo Nordisk Investigational Site	Beijing	Beijing
Germany	Novo Nordisk Investigational Site	Mainz
Israel	Novo Nordisk Investigational Site	Kfar Saba
Italy	Novo Nordisk Investigational Site	Rome
Poland	Novo Nordisk Investigational Site	Warszawa
Portugal	Novo Nordisk Investigational Site	Paco de Arcos
Spain	Novo Nordisk Investigational Site	Madrid
Turkey	Novo Nordisk Investigational Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  China,  Germany,  Israel,  Italy,  Poland,  Portugal,  Spain,  Turkey, 

References & Publications (11)

Caputo S, Maran A, Mannino D, Morano S, Lastoria G, Nicoziani P. Safety and effectiveness of insulin detemir in combination with oral antidiabetic agents in an outpatient specialist setting: results of the Italian SOLVE™ observational study. Minerva Endoc — View Citation

Dzida G, Karnieli E, Svendsen AL, Sølje KS, Hermanns N; SOLVE Study Group.. Depressive symptoms prior to and following insulin initiation in patients with type 2 diabetes mellitus: Prevalence, risk factors and effect on physician resource utilisation. Pri — View Citation

Keating GM. Insulin detemir: a review of its use in the management of diabetes mellitus. Drugs. 2012 Dec 3;72(17):2255-87. doi: 10.2165/11470200-000000000-00000. Review. — View Citation

Khunti K, Caputo S, Damci T, Dzida GJ, Ji Q, Kaiser M, Karnieli E, Liebl A, Ligthelm RJ, Nazeri A, Orozco-Beltran D, Pan C, Ross SA, Svendsen AL, Vora J, Yale JF, Meneghini LF; SOLVE Study Group.. The safety and efficacy of adding once-daily insulin detem — View Citation

Khunti K, Damci T, Husemoen LL, Babu V, Liebl A. Exploring the characteristics of suboptimally controlled patients after 24weeks of basal insulin treatment: An individualized approach to intensification. Diabetes Res Clin Pract. 2017 Jan;123:209-217. doi: — View Citation

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

Morales C, de Luis D, de Arellano AR, Ferrario MG, Lizán L. Cost-Effectiveness Analysis of Insulin Detemir Compared to Neutral Protamine Hagedorn (NPH) in Patients with Type 1 and Type 2 Diabetes Mellitus in Spain. Diabetes Ther. 2015 Dec;6(4):593-610. — View Citation

Orozco-Beltran D, Pan C, Svendsen AL, Faerch L, Caputo S; SOLVE Study Group.. Basal insulin initiation in primary vs. specialist care: similar glycaemic control in two different patient populations. Int J Clin Pract. 2016 Mar;70(3):236-43. doi: 10.1111/ij — View Citation

Pan C, Han P, Ji L, Ji Q, Lu J, Lin J, Liu J, Su B, Shi J, Wang P. Weight-neutral effect of once-daily insulin detemir in Chinese type 2 diabetes patients: subgroup analysis of the SOLVE study. J Diabetes. 2015 Mar;7(2):222-30. doi: 10.1111/1753-0407.1217 — 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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia		during 24 weeks of treatment
Secondary	Incidence of all adverse drug reactions (ADRs)		during 24 weeks of treatment
Secondary	Incidence of major and minor hypoglycaemic events		in the 4 weeks preceding trial start, and at the 12 and 24 week visits
Secondary	HbA1c and its change from trial start		at the 12 and 24 week visits
Secondary	Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start		at the 12 and 24 week visits
Secondary	FBG variability (measured as standard deviation of FBG) and its change from trial start		at the 12 and 24 weeks visits
Secondary	Body weight and its change from trial start		at the 12 and 24 week visits

External Links

•   Clinical Trials at Novo Nordisk