Observational Study on Safety of Self-titration of Once Daily Levemir® (SOLVE™)
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin detemir |
| Study Type: | Observational |
| Study Design: | 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 |
- Incidence of serious adverse drug reactions including major hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
- Incidence of serious adverse events and all adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
- Incidence of hypoglycaemic events [ Time Frame: in the 4 weeks preceding the baseline, 12 and 20 week visits ] [ Designated as safety issue: Yes ]
- HbA1c [ Time Frame: at the interim study visit at 12 weeks and the end of the study visit at 20 weeks ] [ Designated as safety issue: No ]
- Variability and mean of the patient's self-monitored plasma glucose measurements [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo [ Time Frame: defined by the average of the last three FBGs ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
- Frequency of insulin adjustment [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
- Total number of visits/contacts to the clinic, related to titration [ Time Frame: at approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
- HCP time used on titration training [ Time Frame: at baseline and approximately 12 and 20 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 882 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Drug: insulin detemir
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00740519 History of Changes |
| Other Study ID Numbers: | NN304-3573 |
| Study First Received: | August 19, 2008 |
| Last Updated: | June 22, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013