Trial Outcomes & Findings for Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea (NCT NCT00455858)

NCT ID: NCT00455858

Last Updated: 2024-02-01

Results Overview

Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 87 participants
• Primary outcome timeframe: week 0, week 20
• Results posted on: 2024-02-01

Participant Flow

A total of eight study sites in South Korea.

Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).

Participant milestones

Measure	Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Overall Study STARTED	87
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Insulin Detemir Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Overall Study Lost to Follow-up	2
Overall Study Protocol Violation	1
Overall Study Lack of Efficacy	1
Overall Study Well controlled FPG without insulin	1
Overall Study Withdrawal	1

Baseline Characteristics

Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

Baseline characteristics by cohort

Measure	Insulin Detemir n=87 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Age, Continuous	55.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 20

Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.

Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

Outcome measures

Measure	Insulin Detemir n=81 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 HbA1c at baseline	9.3 percentage change in HbA1c Standard Deviation 1.1
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 HbA1c at week 20	8.2 percentage change in HbA1c Standard Deviation 1.1
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 Change in HbA1c from baseline to week 20	-1.2 percentage change in HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: week 0, week 12

Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.

Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline

Outcome measures

Measure	Insulin Detemir n=82 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 HbA1c at week 12	8.2 percentage change in HbA1c Standard Deviation 1.1
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 HbA1c at baseline	9.3 percentage change in HbA1c Standard Deviation 1.1
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 Change in HbA1c from baseline to week 12	-1.2 percentage change in HbA1c Standard Deviation 0.9

SECONDARY outcome

Timeframe: week 0, week 12, week 20

Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.

Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20

Outcome measures

Measure	Insulin Detemir n=85 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Change in Fasting Plasma Glucose (FPG) FPG at baseline, N=81	178 mg/dL Standard Deviation 54.2
Change in Fasting Plasma Glucose (FPG) FPG at week 12, N=77	118 mg/dL Standard Deviation 36.3
Change in Fasting Plasma Glucose (FPG) FPG at week 20, N=78	116 mg/dL Standard Deviation 35.8
Change in Fasting Plasma Glucose (FPG) Change in FPG from baseline to week 12, N=75	-60 mg/dL Standard Deviation 55.8
Change in Fasting Plasma Glucose (FPG) Change in FPG from baseline to week 20, N=73	-62 mg/dL Standard Deviation 61.5

SECONDARY outcome

Timeframe: week 12, week 20

Population: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.

Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%

Outcome measures

Measure	Insulin Detemir n=85 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% Achieving HbA1c < 7% after 12 weeks, N=82	14.6 percentage of participants
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% Not achieving HbA1c < 7% after 12 weeks, N=82	85.4 percentage of participants
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% Achieving HbA1c < 7% after 20 weeks, N=81	12.3 percentage of participants
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% Not achieving HbA1c < 7% after 20 weeks, N=81	87.7 percentage of participants

SECONDARY outcome

Timeframe: weeks 0-20

Population: For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section.

Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.

Outcome measures

Measure	Insulin Detemir n=81 Participants Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Occurence of Hypoglycaemic Episodes Occurence of hypoglycaemic episodes: Diurnal	92 episodes
Occurence of Hypoglycaemic Episodes Occurence of hypoglycaemic episodes: Nocturnal	78 episodes
Occurence of Hypoglycaemic Episodes Occurence of hypoglycaemic episodes: Total	170 episodes

Adverse Events

Insulin Detemir

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Detemir n=87 participants at risk Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Infections and infestations Pyelonephritis acute	1.1% 1/87 • Number of events 1 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
Infections and infestations Pneumonia mycoplasmal	1.1% 1/87 • Number of events 1 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
Cardiac disorders Angina pectoris	1.1% 1/87 • Number of events 1 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
Gastrointestinal disorders Intestinal polyp	1.1% 1/87 • Number of events 1 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	1.1% 1/87 • Number of events 1 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.

Other adverse events

Measure	Insulin Detemir n=87 participants at risk Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Infections and infestations Nasopharyngitis	11.5% 10/87 • Number of events 10 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	5.7% 5/87 • Number of events 5 • Adverse events were collected in a time span of 22 weeks. Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.

Additional Information

Public Access to Clinical Trials

Novo Nordisk A/S

Email: clinicaltrials@novonordisk.com

Results disclosure agreements

• Principal investigator is a sponsor employee Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, should be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
• Publication restrictions are in place

Restriction type: OTHER