A Phase 4 interventional study of insulin detemir and insulin detemir in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 69 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 244 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aggressive FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Conventional FPG (fasting plasma glucose) titration target range group
Drug: insulin detemir
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
Time frame: week 20
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
Time frame: week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
Time frame: week -2, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: * If subject was unable to treat himself: Major incidence. * If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence. * If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
Time frame: weeks 0-20
69 sites in the United States of America (USA).
| Milestone | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Started | 122 | 122 |
| Completed | 107 | 104 |
| Not completed | 15 | 18 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Protocol violation | 8 | 4 |
| Withdrew: Move to another state | 1 | 0 |
| Withdrew: Inclusion criteria were not met | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Lack of time and intolerance to drug | 0 | 1 |
| Withdrew: Discontinued due to injection | 0 | 2 |
| Withdrew: No need of study drug to treat diabetes | 0 | 1 |
| Withdrew: No wish to keep taking avandia | 0 | 1 |
| Withdrew: Subject off study drug for too long | 0 | 1 |
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
| percentage of participants | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% | 64.3 | 54.5 |
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
| percentage of participants | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% | 41.1 | 26.8 |
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
| percentage point change | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline | -1.229 ± 0.061 | -0.958 ± 0.061 |
Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: * If subject was unable to treat himself: Major incidence. * If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence. * If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
| number of events | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| All | 333 | 227 |
| Major | 1 | 0 |
| Minor | 225 | 136 |
| Symptoms only | 107 | 91 |
Collected over Adverse events were collected in a time span of 20 weeks.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FPG 70-90 mg/dL | — | 5/121 (4.1%) | 45/121 (37.2%) |
| FPG 80-110 mg/dL | — | 4/122 (3.3%) | 30/122 (24.6%) |
| Event | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Upper Limb FractureInjury, poisoning and procedural complications | 2/121 | 0/122 |
| Coronary Artery DiseaseCardiac disorders | 1/121 | 0/122 |
| Ventricular TachycardiaCardiac disorders | 1/121 | 0/122 |
| Non-Cardiac Chest PainGeneral disorders | 1/121 | 0/122 |
| FallInjury, poisoning and procedural complications | 1/121 | 0/122 |
| Rib FractureInjury, poisoning and procedural complications | 1/121 | 0/122 |
| Metastases To BoneNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/121 | 0/122 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/121 | 0/122 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/121 | 0/122 |
| Angina PectorisCardiac disorders | 0/121 | 1/122 |
| Event | FPG 70-90 mg/dL | FPG 80-110 mg/dL |
|---|---|---|
| Back PainMusculoskeletal and connective tissue disorders | 7/121 | 2/122 |
| Upper Respiratory Tract InfectionInfections and infestations | 6/121 | 3/122 |
| HeadacheNervous system disorders | 6/121 | 2/122 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/121 | 2/122 |
| Urinary Tract InfectionInfections and infestations | 4/121 | 4/122 |
| Pain In ExtremityMusculoskeletal and connective tissue disorders | 0/121 | 4/122 |
| DiarrhoeaGastrointestinal disorders | 3/121 | 3/122 |
| NauseaGastrointestinal disorders | 3/121 | 1/122 |
| BronchitisInfections and infestations | 3/121 | 1/122 |
| FallInjury, poisoning and procedural complications | 3/121 | 0/122 |
| Age, Continuous(years) | FPG 70-90 mg/dL | FPG 80-110 mg/dL | Total |
|---|---|---|---|
| Mean | 56.6 ± 9.4 | 57.2 ± 10.6 | 56.9 ± 10.0 |
| Sex: Female, Male(Participants) | FPG 70-90 mg/dL | FPG 80-110 mg/dL | Total |
|---|---|---|---|
| Female | 54 | 44 | 98 |
| Male | 68 | 78 | 146 |
| Fasting plasma glucose (FPG)(mg/dL) | FPG 70-90 mg/dL | FPG 80-110 mg/dL | Total |
|---|---|---|---|
| Mean | 164.0 ± 43.1 | 163.1 ± 40.4 | 163.5 ± 41.7 |
| Glycosylated haemoglobin (HbA1c)(percentage) | FPG 70-90 mg/dL | FPG 80-110 mg/dL | Total |
|---|---|---|---|
| Mean | 8.0 ± 0.6 | 7.9 ± 0.6 | 8.0 ± 0.6 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S