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The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sativex | Drug | containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) | The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours" where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis. | Day 0 to Day 98 |
| Number of Responders at the 30% Improvement Level at the End of Treatment | A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period. | Day 0 - Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment | The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Solomon Tesfaye, JCHMT FRCP | Royal Hallamshire Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Hallamshire Hospital | Sheffield | Yorkshire | S10 2JF | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| FG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment) | The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours" where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to Day 98 |
|
All adverse events occurring from the time of consent to post study follow up i.e. 19 weeks were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharm Ltd | 0044 1223 266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
| Placebo | Drug | containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. |
|
|
| Day 0 to Day 98 |
| Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment | The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours" where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment). | Day 0 - Day 98 |
| Subject Global Impression of Change at the End of Treatment | The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented. | Day 0 and Day 98 |
| Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment | The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome. | Day 0 and Day 98 |
| Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale | The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. | Day 0 and Day 98 |
| Change From Baseline in the Use of Rescue Analgesia at the End of Treatment | The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated. | Day 0 - Day 98 |
| Incidence of Adverse Events as a Measure of Subject Safety | The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented. | Day 0 - Day 133 |
| Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment | Subjects rated their intoxication levels on a scale of 0-10, where 0 equals "no intoxication" and 10 equals "extreme intoxication". A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded. | Day 0 - Day 98 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Refused medication, no side effects |
|
| Non-compliance with stable analgesia |
|
| Did not meet entry criteria at visit 1 |
|
| Subject thought medication changed |
|
| Ceased treatment due to travel |
|
| Subject preferred paracetamol |
|
| Felt good so stopped treatment |
|
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sativex |
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| OG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. |
|
|
|
| Secondary | Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment | The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 to Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment | The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours" where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment). | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Day 98 |
|
|
|
|
| Secondary | Subject Global Impression of Change at the End of Treatment | The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Number | participants | Day 0 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment | The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale | The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 and Day 98 |
|
|
|
|
| Secondary | Change From Baseline in the Use of Rescue Analgesia at the End of Treatment | The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | Tablets | Day 0 - Day 98 |
|
|
|
|
| Secondary | Incidence of Adverse Events as a Measure of Subject Safety | The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Number | participants | Day 0 - Day 133 |
|
|
|
| Secondary | Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment | Subjects rated their intoxication levels on a scale of 0-10, where 0 equals "no intoxication" and 10 equals "extreme intoxication". A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded. | The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data. | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Day 98 |
|
|
|
| Primary | Number of Responders at the 30% Improvement Level at the End of Treatment | A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period. | All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders. | Posted | Number | participants | Day 0 - Day 98 |
|
|
|
|
| 14 |
| 149 |
| 120 |
| 149 |
| EG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. | 12 | 148 | 101 | 148 |
| BRADYCARDIA | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| EYE HAEMORRHAGE | Eye disorders | MedDRA 8.1 | Systematic Assessment |
|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| PERIODONTITIS | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 8.1 | Systematic Assessment |
|
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| EXOSTOSIS | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
|
| ESSENTIAL HYPERTENSION | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| PERIPHERAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| ACCELERATED HYPERTENSION | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 8.1 | Systematic Assessment |
|
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Slightly Improved |
|
| No Change |
|
| Slightly worse |
|
| Much worse |
|
| Very much worse |
|