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

February 2, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

882

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Crawley, United Kingdom, RH11 9RT
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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:
  • Levemir®
  • NN304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse drug reactions including major hypoglycaemic events
Time Frame: during treatment
during treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse events and all adverse events
Time Frame: during treatment
during treatment
Incidence of hypoglycaemic events
Time Frame: in the 4 weeks preceding the baseline, 12 and 20 week visits
in the 4 weeks preceding the baseline, 12 and 20 week visits
HbA1c
Time Frame: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
at the interim study visit at 12 weeks and the end of the study visit at 20 weeks
Variability and mean of the patient's self-monitored plasma glucose measurements
Time Frame: at approximately 12 and 20 weeks
at approximately 12 and 20 weeks
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
at approximately 12 and 20 weeks
Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo
Time Frame: defined by the average of the last three FBGs
defined by the average of the last three FBGs
Body weight
Time Frame: at approximately 12 and 20 weeks
at approximately 12 and 20 weeks
Frequency of insulin adjustment
Time Frame: at approximately 12 and 20 weeks
at approximately 12 and 20 weeks
Total number of visits/contacts to the clinic, related to titration
Time Frame: at approximately 12 and 20 weeks
at approximately 12 and 20 weeks
HCP time used on titration training
Time Frame: at baseline and approximately 12 and 20 weeks
at baseline and approximately 12 and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-3573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on insulin detemir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe