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Trial record 2 of 2 for:    NCT00825643

Observational Study on Safety of Self-titration of Once Daily Levemir® (SOLVE™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00740519
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

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Study Type : Observational
Actual Enrollment : 882 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
A Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Other Names:
  • NN304
  • Levemir®

Primary Outcome Measures :
  1. Incidence of serious adverse drug reactions including major hypoglycaemic events [ Time Frame: during treatment ]

Secondary Outcome Measures :
  1. Incidence of serious adverse events and all adverse events [ Time Frame: during treatment ]
  2. Incidence of hypoglycaemic events [ Time Frame: in the 4 weeks preceding the baseline, 12 and 20 week visits ]
  3. HbA1c [ Time Frame: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks ]
  4. Variability and mean of the patient's self-monitored plasma glucose measurements [ Time Frame: at approximately 12 and 20 weeks ]
  5. Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes [ Time Frame: at approximately 12 and 20 weeks ]
  6. Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo [ Time Frame: defined by the average of the last three FBGs ]
  7. Body weight [ Time Frame: at approximately 12 and 20 weeks ]
  8. Frequency of insulin adjustment [ Time Frame: at approximately 12 and 20 weeks ]
  9. Total number of visits/contacts to the clinic, related to titration [ Time Frame: at approximately 12 and 20 weeks ]
  10. HCP time used on titration training [ Time Frame: at baseline and approximately 12 and 20 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from a primary care setting who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing health care professional.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00740519

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United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S Identifier: NCT00740519     History of Changes
Other Study ID Numbers: NN304-3573
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs