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Completed

NCT Number: NCT00740519

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.

Other names: NN304, Levemir®

Primary outcomes

  1. Incidence of serious adverse drug reactions including major hypoglycaemic events

    Time frame: during treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: SOLVE™

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 25, 2008
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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