DiabetesSOLVE™NCT00825643
Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 9 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 18,481 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Apr 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
China1 site
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100004
Turkey (Türkiye)1 site
Novo Nordisk Investigational Site
Istanbul, 34335
About this study
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
Also called NN304, Levemir®
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
Measured: during 24 weeks of treatment
Secondary outcomes (6)
Incidence of all adverse drug reactions (ADRs)
Measured: during 24 weeks of treatment
Incidence of major and minor hypoglycaemic events
Measured: in the 4 weeks preceding trial start, and at the 12 and 24 week visits
HbA1c and its change from trial start
Measured: at the 12 and 24 week visits
Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start
Measured: at the 12 and 24 week visits
FBG variability (measured as standard deviation of FBG) and its change from trial start
Measured: at the 12 and 24 weeks visits
Body weight and its change from trial start
Measured: at the 12 and 24 week visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825643
- Sponsor's protocol ID
- NN304-3714
- Acronym
- SOLVE™
- Status last verified
- Feb 2017
- First submitted
- 20 Jan 2009
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2012 Jul;14(7):654-61. doi: 10.1111/j.1463-1326.2012.01602.x. Epub 2012 Apr 22.
PubMed 22443213Khunti 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 detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. Diabetes Obes Metab. 2012 Dec;14(12):1129-36. doi: 10.1111/j.1463-1326.2012.01665.x. Epub 2012 Aug 30.
PubMed 22830956Keating 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.
PubMed 23110609Ross 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 practice. J Diabetes. 2014 May;6(3):243-50. doi: 10.1111/1753-0407.12091. Epub 2013 Oct 29.
PubMed 24103141Vora J, Caputo S, Damci T, Orozco-Beltran D, Pan C, Svendsen AL, Solje 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. doi: 10.1111/jcpt.12116. Epub 2013 Dec 13.
PubMed 24329524Pan 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: 10.1111/1753-0407.12179. Epub 2014 Sep 4.
PubMed 24909984Dzida G, Karnieli E, Svendsen AL, Solje 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. Prim Care Diabetes. 2015 Oct;9(5):346-53. doi: 10.1016/j.pcd.2015.01.002. Epub 2015 Jan 30.
PubMed 25649990Caputo 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 Endocrinol. 2015 Dec;40(4):249-58.
PubMed 26551483Morales C, de Luis D, de Arellano AR, Ferrario MG, Lizan 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. doi: 10.1007/s13300-015-0143-x. Epub 2015 Nov 20.
PubMed 26589521Orozco-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/ijcp.12776. Epub 2016 Feb 24.
PubMed 26916450Khunti 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: 10.1016/j.diabres.2016.11.028. Epub 2016 Dec 9.
PubMed 28061430Pan C, Ji L, Lu J, Yang W, Zhou Z; Chinese SOLVE Study. [Effectiveness and safety of initiation of once-daily insulin detemir in Chinese patients with type 2 diabetes previously treated with different quantities of oral anti-diabetic drugs: subgroup analysis of the Chinese SOLVE Study]. Zhonghua Nei Ke Za Zhi. 2015 Jul;54(7):612-7. Chinese.
PubMed 26359024Damci T, Emral R, Svendsen AL, Balkir T, Vora J; SOLVE study group. Lower risk of hypoglycaemia and greater odds for weight loss with initiation of insulin detemir compared with insulin glargine in Turkish patients with type 2 diabetes mellitus: local results of a multinational observational study. BMC Endocr Disord. 2014 Jul 21;14:61. doi: 10.1186/1472-6823-14-61.
PubMed 25048824Yale JF, Damci T, Kaiser M, Karnieli E, Khunti K, Liebl A, Baeres FM, Svendsen AL, Ross SA; SOLVE Study Group. Initiation of once daily insulin detemir is not associated with weight gain in patients with type 2 diabetes mellitus: results from an observational study. Diabetol Metab Syndr. 2013 Oct 2;5(1):56. doi: 10.1186/1758-5996-5-56.
PubMed 24499517Liebl A, Andersen H, Svendsen AL, Vora J, Yale JF; SOLVE Study Group. Resource utilisation and quality of life following initiation of insulin detemir in patients with type 2 diabetes mellitus. Int J Clin Pract. 2013 Aug;67(8):740-9. doi: 10.1111/ijcp.12133.
PubMed 23869677
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00825643
- Acronym / sponsor ID
- SOLVE™ / NN304-3714
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,481 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | – | Drug: insulin detemir |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® as new treatment and as part of routine out-patient care by the prescribing physician
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin detemirAlso: NN304, Levemir®Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation | Drug | Insulin detemir |
Primary outcome
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia
Time frame: during 24 weeks of treatment
6 secondary outcomes
Incidence of all adverse drug reactions (ADRs)
Time frame: during 24 weeks of treatment
Incidence of major and minor hypoglycaemic events
Time frame: in the 4 weeks preceding trial start, and at the 12 and 24 week visits
HbA1c and its change from trial start
Time frame: at the 12 and 24 week visits
Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start
Time frame: at the 12 and 24 week visits
FBG variability (measured as standard deviation of FBG) and its change from trial start
Time frame: at the 12 and 24 weeks visits
Body weight and its change from trial start
Time frame: at the 12 and 24 week visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Results publication: PubMed 22443213Khunti 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. 2012 Jul;14(7):654-61. doi: 10.1111/j.1463-1326.2012.01602.x. Epub 2012 Apr 22.
- Results publication: PubMed 22830956Khunti 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 detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. Diabetes Obes Metab. 2012 Dec;14(12):1129-36. doi: 10.1111/j.1463-1326.2012.01665.x. Epub 2012 Aug 30.
- Results publication: PubMed 23110609Keating 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.
- Results publication: PubMed 24103141Ross 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 practice. J Diabetes. 2014 May;6(3):243-50. doi: 10.1111/1753-0407.12091. Epub 2013 Oct 29.
- Results publication: PubMed 24329524Vora J, Caputo S, Damci T, Orozco-Beltran D, Pan C, Svendsen AL, Solje 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. doi: 10.1111/jcpt.12116. Epub 2013 Dec 13.
- Results publication: PubMed 24909984Pan 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: 10.1111/1753-0407.12179. Epub 2014 Sep 4.
- Results publication: PubMed 25649990Dzida G, Karnieli E, Svendsen AL, Solje 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. Prim Care Diabetes. 2015 Oct;9(5):346-53. doi: 10.1016/j.pcd.2015.01.002. Epub 2015 Jan 30.
- Results publication: PubMed 26551483Caputo 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 Endocrinol. 2015 Dec;40(4):249-58.
- Results publication: PubMed 26589521Morales C, de Luis D, de Arellano AR, Ferrario MG, Lizan 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. doi: 10.1007/s13300-015-0143-x. Epub 2015 Nov 20.
- Results publication: PubMed 26916450Orozco-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/ijcp.12776. Epub 2016 Feb 24.
- Results publication: PubMed 28061430Khunti 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: 10.1016/j.diabres.2016.11.028. Epub 2016 Dec 9.
- Derived from this study: PubMed 26359024Pan C, Ji L, Lu J, Yang W, Zhou Z; Chinese SOLVE Study. [Effectiveness and safety of initiation of once-daily insulin detemir in Chinese patients with type 2 diabetes previously treated with different quantities of oral anti-diabetic drugs: subgroup analysis of the Chinese SOLVE Study]. Zhonghua Nei Ke Za Zhi. 2015 Jul;54(7):612-7. Chinese.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, China, Germany, Israel, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia (time frame: during 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825643, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.